Methods and systems for implanting a joint implant

ABSTRACT

Methods, systems, and devices for treating osteochondral defects (OCDs) are disclosed. The disclosed methods and systems include collecting joint surface data using image-free methods, generating a three-dimensional (3D) healthy bone model based on the joint surface data and a database of healthy bone anatomies, defining the OCD boundary on the joint, generating a 3D implant model based on the 3D healthy bone model and the OCD boundary, manufacturing an implant based on the 3D implant model, generating an implantation plan, the resected cavity on the joint. The implant includes a 3D-printed titanium alloy substrate having a first and second porous layer separated by a nonporous layer. A polymer material is over-molded onto the second porous layer and treated to exhibit properties that mimic cartilage, while the first porous layer allows the implant to fuse to patient bone.

PRIORITY

The present application claims priority to U.S. Provisional PatentApplication No. 62/876,180, titled “METHODS AND SYSTEMS FOR IMPLANTING AJOINT IMPLANT,” filed Jul. 19, 2019, and U.S. Provisional PatentApplication No. 62/901,434, titled “METHODS AND SYSTEMS FOR IMPLANTING AJOINT IMPLANT,” filed Sep. 17, 2019, each of which is herebyincorporated by reference herein in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to methods, systems, andapparatuses related to a computer-assisted surgical system that includesvarious hardware and software components that work together to enhancesurgical workflows. More particularly, the present disclosure relates tomedical devices for the treatment and repair of osteochondral defectsand to methods, devices, and systems for designing, fabricating, andimplanting such medical devices. The disclosed techniques may be appliedto, for example, shoulder, hip, and knee surgical procedures, as well asother surgical interventions such as arthroscopic procedures, spinalprocedures, maxillofacial procedures, rotator cuff procedures, ligamentrepair and replacement procedures.

BACKGROUND

Articular cartilage is the smooth tissue that covers the ends of boneswhere they abut to form joints and allows the ends of bones to glide inproximity to each other with little friction when the joint is inmotion. Damage to articular cartilage, sometimes referred to asarticular lesions, can be caused by trauma, disease (e.g.,osteoarthritic degradation), or age. The body does not readily repairdamaged cartilage because cartilage does not have direct access to thebody's blood supply to surround damaged tissue and provide factorspromoting regeneration. Articular lesions can result in further damageto the subchondral bone if not treated. Such damage is commonly referredto as an osteochondral defect (OCD). In weight-bearing joints (i.e., theankles, knees, and hips), OCDs may be associated with pain, loss offunction, and long-term complications, such as osteoarthritis. Articularlesions and OCDs can vary widely in size, location, and the degree ofdamage they may cause. As a result, a treatment plan for a patient withan articular lesion or OCD must be customized to the patient andrequires a thorough assessment of the articular lesion or OCD for anumber of factors, including the location and size of the articularlesion or OCD and the age and activity level of the patient.

In most cases, surgical treatment, for example arthroscopic surgery, ofan articular lesion or OCD is necessary to provide relief for thepatient from pain and other symptoms. Arthroscopic surgery optionsinclude, for example, debridement, microfracture, abrasion arthroplasty,osteochondral autograft transplantation (OATS, also known asmosaicplasty), and autologous chondrocyte implantation (ACI).

Synthetic implants that replace the damaged cartilage and subchondralbone are also used for the treatment of OCDs. These implant devices usedto treat OCDs vary in size and material depending on the location of theOCD on the articular joint. Commercially available implants include theArthrosurface HemiCAP, the BioPoly RS system, and the Episurf Episealer.These implants can range from cobalt chrome plugs anchored into the boneto porous scaffolds seeded with cells to induce chondrification.However, biointegration of synthetic implants into the patient's nativejoint can be challenging and may vary by patient. Existing syntheticimplants typically have pre-defined shapes and sizes, requiring theremoval of healthy tissue to conform to the implant during installation.Synthetic implants may also result in incongruence with the surroundingarticular surface. Further, damage to the subchondral bone in an OCD maydestroy the original contours of the bone and make restoring the normalpressures of the knee more difficult. In addition, some implants aremade of metal and are nonporous. Such implants may cause damage tocartilage opposing the implants. Moreover, the potential exists forimplants to loosen due to an imprecise fit in the joint. This can beexacerbated by the sheer and impact forces experienced in aweight-bearing joint, such as a knee.

While there have been some efforts to utilize interpenetrating polymernetwork (IPN) and semi-interpenetrating polymer network (semi-IPN)structures, these efforts have generally failed to demonstratesuccessful adhesion to patient bone surfaces. While some polymers haveshown success in providing low-friction durable surfaces that maysimulate natural cartilage, these often have trouble bonding to bonestructures as they heal. This can be problematic given the large amountof stress applied to osteochondral tissue.

SUMMARY

This summary is provided to comply with 37 C.F.R. § 1.73, require asummary of the invention briefly indicating the nature and substance ofthe invention. It is submitted with the understanding that it will notbe used to interpret or limit the scope or meaning of the presentdisclosure.

A method of treating an osteochondral defect in a joint of a patient isprovided. The method includes mapping a joint surface of the joint ofthe patient using a probe; generating a three-dimensionalpatient-specific healthy bone model based on the mapping of the jointsurface and a database of healthy bone anatomies; defining anosteochondral defect lesion boundary on the joint surface using theprobe; generating a three-dimensional patient-specific implant model;manufacturing or selecting a patient-specific implant intraoperativelybased at least on the three-dimensional patient-specific implant model;generating an implantation plan; resecting the joint to create a cavityon the joint using a surgical robot based on the implantation plan; andplacing the patient-specific implant into the cavity.

An exemplary implant is manufactured by 3D printing a titanium alloysubstrate having a first and second porous layer separated by anonporous layer. A polymer material is over-molded onto the secondporous layer and treated to exhibit properties that mimic cartilage,while the first porous layer allows the implant to fuse to patient bone.

In some embodiments, there is provided a method of placing an implant totreat a defect associated with an articular surface of a joint of apatient. The method may comprise: receiving first data associated withthe articular surface, the first data indicating a surface geometry ofthe articular surface; generating, using the first data, a bone modelcorresponding to bone tissue associated with the articular surface;defining a geometry of the defect; generating, using the bone model andthe geometry of the defect, an implant model configured to treat thedefect; receiving an implant corresponding to the implant model;generating an implantation plan for the implant, wherein theimplantation plan comprises at least one of a size, a shape, a location,or an orientation of a cavity at the articular surface that isconfigured to receive the implant; resecting the articular surface tocreate the cavity; placing the implant into the cavity; receiving seconddata associated with the articular surface, the second data indicating apost-implantation surface geometry of the articular surface; anddetermining, based on the post-implantation surface geometry, whether amodification is needed to the implant for the implant to be congruentwith the articular surface.

In some embodiments, receiving the first data comprises collecting,using a tool configured to map a surface, first surface point dataassociated with the articular surface.

In some embodiments, the tool comprises an instrumented probe configuredto be identified by a tracking system.

In some embodiments, defining the geometry of the defect comprisesdefining, using the tool, a boundary of the defect.

In some embodiments, receiving the second data comprises collecting,using the tool, second surface point data associated with the articularsurface after placement of the implant.

In some embodiments, receiving the first data comprises receiving apreoperative image of the articular surface.

In some embodiments, the preoperative image is obtained using at leastone of X-ray imaging, computerized tomography scanning, or magneticresonance imaging.

In some embodiments, a cross-sectional shape of the implant defined bythe implant model is based on the geometry of the defect.

In some embodiments, an implant articular surface of the implant definedby the implant model is based on a portion of the bone tissue defined bythe bone model that lies within the geometry of the defect.

In some embodiments, generating the implantation plan comprises:orienting the implant model with respect to the bone model; anddetermining the location and the orientation of the cavity according toan implant model orientation of the implant model with respect to thebone model.

In some embodiments, resecting the articular surface comprises removingthe defect from the articular surface.

In some embodiments, removing the defect from the articular surfacecomprises controlling at least one of a speed or a depth of a burr.

In some embodiments, removing the defect from the articular surfacecomprises stopping a burr when the burr reaches a boundary of thecavity.

In some embodiments, placing the implant into the cavity comprisespress-fitting the implant into the cavity.

In some embodiments, placing the implant into the cavity comprisesapplying an adhesive to adhere the implant to the articular surface.

In some embodiments, the implant comprises a tissue-interfacing surfaceconfigured to encourage bone growth into the implant.

In some embodiments, the tissue-interfacing surface comprises a porousmatrix configured to permit ingrowth of at least one of cortical orcancellous bone.

In some embodiments, receiving the implant comprises manufacturing theimplant according to the implant model.

In some embodiments, receiving the implant comprises selecting theimplant that best corresponds to the implant model from a plurality ofpre-existing implants.

In some embodiments, determining whether the modification is needed tothe implant comprises: receiving healthy bone anatomy data from adatabase; and comparing the post-implantation surface geometry to thehealthy bone anatomy data.

In some embodiments, comparing the post-implantation surface geometry tothe healthy bone anatomy data comprises calculating at least one of anoverlapping metric, a volume metric, or a surface metric associated withthe post-implantation surface geometry and the healthy bone anatomydata.

In some embodiments, the method may further comprise shaving or planingan implant articular surface of the implant, according to whether themodification is needed to the implant.

In some embodiments, the implant articular surface comprises a syntheticcartilage surface; and shaving or planing the implant articular surfacecomprises shaving or planing the synthetic cartilage surface until thesynthetic cartilage surface smoothly interfaces with surrounding bonetissue of the articular surface of the joint.

In some embodiments, the defect comprises an osteochondral defect.

In some embodiments, there is provided a system for treating a defectassociated with an articular surface of a joint. The system maycomprise: a surgical system; a processor operably coupled to thesurgical system, the processor configured to: receive, from the surgicalsystem, first data associated with the articular surface, the first dataindicating a surface geometry of the articular surface; generate, usingthe first data, a bone model corresponding to bone tissue associatedwith the articular surface; receive a geometry of the defect; generate,using the bone model and the geometry of the defect, an implant modeldefining an implant configured to treat the defect; generate animplantation plan for the implant, wherein the implantation plancomprises at least one of a size, a shape, a location, or an orientationof a cavity at the articular surface that is configured to receive theimplant; receive second data associated with the articular surface, thesecond data indicating a post-implantation surface geometry of thearticular surface; and determine, based on the post-implantation surfacegeometry, whether a modification is needed to the implant for theimplant to be congruent with the articular surface.

In some embodiments, the surgical system comprises a tool configured tomap a surface.

In some embodiments, the tool comprises an instrumented probe configuredto be identified by a tracking system coupled to the processor.

In some embodiments, the geometry of the defect comprises a boundary ofthe defect defined using the tool.

In some embodiments, the first data comprises first surface point dataassociated with the articular surface collected via the tool.

In some embodiments, the surgical system comprises an imaging device;and the first data comprises a preoperative image of the articularsurface received from the imaging device.

In some embodiments, the imaging device comprises at least one of X-rayimaging device, computerized tomography scanner, or magnetic resonanceimaging device.

In some embodiments, the second data comprises second surface point dataassociated with the articular surface after placement of the implantcollected using the tool.

In some embodiments, a cross-sectional shape of the implant defined bythe implant model is based on the geometry of the defect.

In some embodiments, an implant articular surface of the implant definedby the implant model is based on a portion of the bone tissue defined bythe bone model that lies within the geometry of the defect.

In some embodiments, the processor is configured to generate theimplantation plan by: orienting the implant model with respect to thebone model; and determining the location and the orientation of thecavity according to an implant model orientation of the implant modelwith respect to the bone model.

In some embodiments, the surgical system comprises a resecting toolconfigured to remove the defect from the articular surface.

In some embodiments, the resecting tool comprises a burr.

In some embodiments, the processor is further configured to control atleast one of a speed or a depth of the burr.

In some embodiments, the processor is further configured to stop theburr when the burr reaches a boundary of the cavity.

In some embodiments, the processor is further configured to select theimplant that corresponds to the implant model from a plurality ofpre-existing implants.

In some embodiments, the processor is operably coupled to a databasecomprising healthy bone anatomy data; and the processor is configured todetermine whether the modification is needed to the implant by:retrieving the healthy bone anatomy data from the database, andcomparing the post-implantation surface geometry to the healthy boneanatomy data.

In some embodiments, the processor is configured to compare thepost-implantation surface geometry to the healthy bone anatomy data bycalculating at least one of an overlapping metric, a volume metric, or asurface metric associated with the post-implantation surface geometryand the healthy bone anatomy data.

In some embodiments, the defect comprises an osteochondral defect.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate the embodiments of the invention andtogether with the written description serve to explain the principles,characteristics, and features of the invention. In the drawings:

FIG. 1 depicts an operating theatre including an illustrativecomputer-assisted surgical system (CASS) in accordance with anembodiment.

FIG. 2 depicts an example of an electromagnetic sensor device accordingto some embodiments.

FIG. 3A depicts an alternative example of an electromagnetic sensordevice, with three perpendicular coils, according to some embodiments.

FIG. 3B depicts an alternative example of an electromagnetic sensordevice, with two nonparallel, affixed coils, according to someembodiments.

FIG. 3C depicts an alternative example of an electromagnetic sensordevice, with two nonparallel, separate coils, according to someembodiments.

FIG. 4 depicts an example of electromagnetic sensor devices and apatient bone according to some embodiments

FIG. 5A depicts illustrative control instructions that a surgicalcomputer provides to other components of a CASS in accordance with anembodiment.

FIG. 5B depicts illustrative control instructions that components of aCASS provide to a surgical computer in accordance with an embodiment.

FIG. 5C depicts an illustrative implementation in which a surgicalcomputer is connected to a surgical data server via a network inaccordance with an embodiment.

FIG. 6 depicts an operative patient care system and illustrative datasources in accordance with an embodiment.

FIG. 7A depicts an illustrative flow diagram for determining apre-operative surgical plan in accordance with an embodiment.

FIG. 7B depicts an illustrative flow diagram for determining an episodeof care including pre-operative, intraoperative, and post-operativeactions in accordance with an embodiment.

FIG. 7C depicts illustrative graphical user interfaces including imagesdepicting an implant placement in accordance with an embodiment.

FIG. 8 depicts a flow diagram of an image-free method for treatment ofan OCD of a joint in accordance with an embodiment.

FIG. 9 depicts a flow diagram illustrating a method for generating a 3Dhealthy bone model in accordance with the embodiment of FIG. 8.

FIG. 10 depicts a block diagram of an image-free system for treatment ofan OCD of a joint in accordance with an embodiment.

FIG. 11 depicts a cross-sectional view of an exemplary implantmanufactured in accordance with some embodiments.

FIG. 12 depicts a side view of an exemplary synthetic cartilage implantin accordance with some embodiments.

FIGS. 13-15 depict top view outlines of exemplary synthetic cartilageshapes in accordance with some embodiments.

DETAILED DESCRIPTION

This disclosure is not limited to the particular systems, devices andmethods described, as these may vary. The terminology used in thedescription is for the purpose of describing the particular versions orembodiments only, and is not intended to limit the scope.

The present disclosure describes patient-specific implants for thetreatment of an OCD on a patient's joint, methods for the treatment ofOCDs using such implants, and systems for treatment of OCDs using suchimplants.

In some embodiments, by combining the information obtained from mappingthe surface of the patient's joint surrounding the OCD with a databaseof healthy bone anatomies, an implant may be installed that achieves acongruent and smooth articular surface and restores the contours of ahealthy joint articular surface. In the following description, forpurposes of explanation, numerous specific details are set forth inorder to provide a thorough understanding of example embodiments. Itwill be evident to one skilled in the art, however, that embodiments canbe practiced without these specific details.

As used in this document, the singular forms “a,” “an,” and “the”include plural references unless the context clearly dictates otherwise.Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art. Nothing in this disclosure is to be construed as anadmission that the embodiments described in this disclosure are notentitled to antedate such disclosure by virtue of prior invention. Asused in this document, the term “comprising” means “including, but notlimited to.”

Definitions

For the purposes of this specification, the term “implant” is used torefer to a prosthetic device or structure manufactured to replace orenhance a biological structure, either permanently or on a trial basis.For example, in a knee replacement procedure, an implant can be placedon one or both of the tibia and the femur. While the term “implant” isgenerally considered to denote a man-made structure (as contrasted witha transplant), for the purposes of this specification, an implant caninclude a biological tissue or material transplanted to replace orenhance a biological structure.

For the purposes of this disclosure, the term “real-time” is used torefer to calculations or operations performed on-the-fly as events occuror input is received by the operable system. However, the use of theterm “real-time” is not intended to preclude operations that cause somelatency between input and response, so long as the latency is anunintended consequence induced by the performance characteristics of themachine.

Although much of this disclosure refers to surgeons or other medicalprofessionals by specific job title or role, nothing in this disclosureis intended to be limited to a specific job title or function. Surgeonsor medical professionals can include any doctor, nurse, medicalprofessional, or technician. Any of these terms or job titles can beused interchangeably with the user of the systems disclosed hereinunless otherwise explicitly demarcated. For example, a reference to asurgeon could also apply, in some embodiments to a technician or nurse.

The systems, methods, and devices disclosed herein are particularly welladapted for surgical procedures that utilize surgical navigationsystems, such as the NAVIO® surgical navigation system. NAVIO is aregistered trademark of BLUE BELT TECHNOLOGIES, INC. of Pittsburgh, Pa.,which is a subsidiary of SMITH & NEPHEW, INC. of Memphis, Tenn.

CASS Ecosystem Overview

FIG. 1 provides an illustration of an example computer-assisted surgicalsystem (CASS) 100, according to some embodiments. As described infurther detail in the sections that follow, the CASS uses computers,robotics, and imaging technology to aid surgeons in performingorthopedic surgery procedures such as total knee arthroplasty (TKA) ortotal hip arthroplasty (THA). For example, surgical navigation systemscan aid surgeons in locating patient anatomical structures, guidingsurgical instruments, and implanting medical devices with a high degreeof accuracy. Surgical navigation systems such as the CASS 100 oftenemploy various forms of computing technology to perform a wide varietyof standard and minimally invasive surgical procedures and techniques.Moreover, these systems allow surgeons to more accurately plan, trackand navigate the placement of instruments and implants relative to thebody of a patient, as well as conduct pre-operative and intra-operativebody imaging.

An Effector Platform 105 positions surgical tools relative to a patientduring surgery. The exact components of the Effector Platform 105 willvary, depending on the embodiment employed. For example, for a kneesurgery, the Effector Platform 105 may include an End Effector 105B thatholds surgical tools or instruments during their use. The End Effector105B may be a handheld device or instrument used by the surgeon (e.g., aNAVIO® hand piece or a cutting guide or jig) or, alternatively, the EndEffector 105B can include a device or instrument held or positioned by aRobotic Arm 105A. While one Robotic Arm 105A is illustrated in FIG. 1,in some embodiments there may be multiple devices. As examples, theremay be one Robotic Arm 105A on each side of an operating table T or twodevices on one side of the table T. The Robotic Arm 105A may be mounteddirectly to the table T, be located next to the table T on a floorplatform (not shown), mounted on a floor-to-ceiling pole, or mounted ona wall or ceiling of an operating room. The floor platform may be fixedor moveable. In one particular embodiment, the robotic arm 105A ismounted on a floor-to-ceiling pole located between the patient's legs orfeet. In some embodiments, the End Effector 105B may include a sutureholder or a stapler to assist in closing wounds. Further, in the case oftwo robotic arms 105A, the surgical computer 150 can drive the roboticarms 105A to work together to suture the wound at closure.Alternatively, the surgical computer 150 can drive one or more roboticarms 105A to staple the wound at closure.

The Effector Platform 105 can include a Limb Positioner 105C forpositioning the patient's limbs during surgery. One example of a LimbPositioner 105C is the SMITH AND NEPHEW SPIDER2 system. The LimbPositioner 105C may be operated manually by the surgeon or alternativelychange limb positions based on instructions received from the SurgicalComputer 150 (described below). While one Limb Positioner 105C isillustrated in FIG. 1, in some embodiments there may be multipledevices. As examples, there may be one Limb Positioner 105C on each sideof the operating table T or two devices on one side of the table T. TheLimb Positioner 105C may be mounted directly to the table T, be locatednext to the table T on a floor platform (not shown), mounted on a pole,or mounted on a wall or ceiling of an operating room. In someembodiments, the Limb Positioner 105C can be used in non-conventionalways, such as a retractor or specific bone holder. The Limb Positioner105C may include, as examples, an ankle boot, a soft tissue clamp, abone clamp, or a soft-tissue retractor spoon, such as a hooked, curved,or angled blade. In some embodiments, the Limb Positioner 105C mayinclude a suture holder to assist in closing wounds.

The Effector Platform 105 may include tools, such as a screwdriver,light, or laser, to indicate an axis or plane, bubble level, pin driver,pin puller, plane checker, pointer, finger, or some combination thereof.

Resection Equipment 110 (not shown in FIG. 1) performs bone or tissueresection using, for example, mechanical, ultrasonic, or lasertechniques. Examples of Resection Equipment 110 include drillingdevices, burring devices, oscillatory sawing devices, vibratoryimpaction devices, reamers, ultrasonic bone cutting devices, radiofrequency ablation devices, reciprocating devices (such as a rasp orbroach), and laser ablation systems. In some embodiments, the ResectionEquipment 110 is held and operated by the surgeon during surgery. Inother embodiments, the Effector Platform 105 may be used to hold theResection Equipment 110 during use.

The Effector Platform 105 can also include a cutting guide or jig 105Dthat is used to guide saws or drills used to resect tissue duringsurgery. Such cutting guides 105D can be formed integrally as part ofthe Effector Platform 105 or Robotic Arm 105A, or cutting guides can beseparate structures that can be matingly and/or removably attached tothe Effector Platform 105 or Robotic Arm 105A. The Effector Platform 105or Robotic Arm 105A can be controlled by the CASS 100 to position acutting guide or jig 105D adjacent to the patient's anatomy inaccordance with a pre-operatively or intraoperatively developed surgicalplan such that the cutting guide or jig will produce a precise bone cutin accordance with the surgical plan.

The Tracking System 115 uses one or more sensors to collect real-timeposition data that locates the patient's anatomy and surgicalinstruments. For example, for TKA procedures, the Tracking System mayprovide a location and orientation of the End Effector 105B during theprocedure. In addition to positional data, data from the Tracking System115 can also be used to infer velocity/acceleration ofanatomy/instrumentation, which can be used for tool control. In someembodiments, the Tracking System 115 may use a tracker array attached tothe End Effector 105B to determine the location and orientation of theEnd Effector 105B. The position of the End Effector 105B may be inferredbased on the position and orientation of the Tracking System 115 and aknown relationship in three-dimensional space between the TrackingSystem 115 and the End Effector 105B. Various types of tracking systemsmay be used in various embodiments of the present invention including,without limitation, Infrared (IR) tracking systems, electromagnetic (EM)tracking systems, video or image based tracking systems, and ultrasoundregistration and tracking systems. Using the data provided by thetracking system 115, the surgical computer 150 can detect objects andprevent collision. For example, the surgical computer 150 can preventthe Robotic Arm 105A and/or the End Effector 105B from colliding withsoft tissue.

Any suitable tracking system can be used for tracking surgical objectsand patient anatomy in the surgical theatre. For example, a combinationof IR and visible light cameras can be used in an array. Variousillumination sources, such as an IR LED light source, can illuminate thescene allowing three-dimensional imaging to occur. In some embodiments,this can include stereoscopic, tri-scopic, quad-scopic, etc. imaging. Inaddition to the camera array, which in some embodiments is affixed to acart, additional cameras can be placed throughout the surgical theatre.For example, handheld tools or headsets worn by operators/surgeons caninclude imaging capability that communicates images back to a centralprocessor to correlate those images with images captured by the cameraarray. This can give a more robust image of the environment for modelingusing multiple perspectives. Furthermore, some imaging devices may be ofsuitable resolution or have a suitable perspective on the scene to pickup information stored in quick response (QR) codes or barcodes. This canbe helpful in identifying specific objects not manually registered withthe system. In some embodiments, the camera may be mounted on theRobotic Arm 105A.

Although, as discussed herein, the majority of tracking and/ornavigation techniques utilize image-based tracking systems (e.g., IRtracking systems, video or image based tracking systems, etc.). However,electromagnetic (EM) based tracking systems are becoming more common fora variety of reasons. For example, implantation of standard opticaltrackers requires tissue resection (e.g., down to the cortex) as well assubsequent drilling and driving of cortical pins. Additionally, becauseoptical trackers require a direct line of sight with a tracking system,the placement of such trackers may need to be far from the surgical siteto ensure they do not restrict the movement of a surgeon or medicalprofessional.

Generally, EM based tracking devices include one or more wire coils anda reference field generator. The one or more wire coils may be energized(e.g., via a wired or wireless power supply). Once energized, the coilcreates an electromagnetic field that can be detected and measured(e.g., by the reference field generator or an additional device) in amanner that allows for the location and orientation of the one or morewire coils to be determined. As should be understood by someone ofordinary skill in the art, a single coil, such as is shown in FIG. 2, islimited to detecting five (5) total degrees-of-freedom (DOF). Forexample, sensor 200 may be able to track/determine movement in the X, Y,or Z direction, as well as rotation around the Y-axis 202 or Z-axis 201.However, because of the electromagnetic properties of a coil, it is notpossible to properly track rotational movement around the X axis.

Accordingly, in most electromagnetic tracking applications, a three coilsystem, such as that shown in FIG. 3A is used to enable tracking in allsix degrees of freedom that are possible for a rigid body moving in athree-dimensional space (i.e., forward/backward 310, up/down 320,left/right 330, roll 340, pitch 350, and yaw 360). However, theinclusion of two additional coils and the 90° offset angles at whichthey are positioned may require the tracking device to be much larger.Alternatively, as one of skill in the art would know, less than threefull coils may be used to track all 6 DOF. In some EM based trackingdevices, two coils may be affixed to each other, such as is shown inFIG. 3B. Because the two coils 301B and 302B are rigidly affixed to eachother, not perfectly parallel, and have locations that are knownrelative to each other, it is possible to determine the sixth degree offreedom 303B with this arrangement.

Although the use of two affixed coils (e.g., 301B and 302B) allows forEM based tracking in 6 DOF, the sensor device is substantially larger indiameter than a single coil because of the additional coil. Thus, thepractical application of using an EM based tracking system in a surgicalenvironment may require tissue resection and drilling of a portion ofthe patient bone to allow for insertion of a EM tracker. Alternatively,in some embodiments, it may be possible to implant/insert a single coil,or 5 DOF EM tracking device, into a patient bone using only a pin (e.g.,without the need to drill or carve out substantial bone).

Thus, as described herein, a solution is needed for which the use of anEM tracking system can be restricted to devices small enough to beinserted/embedded using a small diameter needle or pin (i.e., withoutthe need to create a new incision or large diameter opening in thebone). Accordingly, in some embodiments, a second 5 DOF sensor, which isnot attached to the first, and thus has a small diameter, may be used totrack all 6 DOF. Referring now to FIG. 3C, in some embodiments, two 5DOF EM sensors (e.g., 301C and 302C) may be inserted into the patient(e.g., in a patient bone) at different locations and with differentangular orientations (e.g., angle 303C is non-zero).

Referring now to FIG. 4, an example embodiment is shown in which a first5 DOF EM sensor 401 and a second 5 DOF EM sensor 402 are inserted intothe patient bone 403 using a standard hollow needle 405 that is typicalin most OR(s). In a further embodiment, the first sensor 401 and thesecond sensor 402 may have an angle offset of “a” 404. In someembodiments, it may be necessary for the offset angle “α” 404 to begreater than a predetermined value (e.g., a minimum angle of 0.50°,0.75°, etc.). This minimum value may, in some embodiments, be determinedby the CASS and provided to the surgeon or medical professional duringthe surgical plan. In some embodiments, a minimum value may be based onone or more factors, such as, for example, the orientation accuracy ofthe tracking system, a distance between the first and second EM sensors.The location of the field generator, a location of the field detector, atype of EM sensor, a quality of the EM sensor, patient anatomy, and thelike.

Accordingly, as discussed herein, in some embodiments, a pin/needle(e.g., a cannulated mounting needle, etc.) may be used to insert one ormore EM sensors. Generally, the pin/needle would be a disposablecomponent, while the sensors themselves may be reusable. However, itshould be understood that this is only one potential system, and thatvarious other systems may be used in which the pin/needle and/or EMsensors are independently disposable or reusable. In a furtherembodiment, the EM sensors may be affixed to the mounting needle/pin(e.g., using a luer-lock fitting or the like), which can allow for quickassembly and disassembly. In additional embodiments, the EM sensors mayutilize an alternative sleeve and/or anchor system that allows forminimally invasive placement of the sensors.

In another embodiment, the above systems may allow for a multi-sensornavigation system that can detect and correct for field distortions thatplague electromagnetic tracking systems. It should be understood thatfield distortions may result from movement of any ferromagneticmaterials within the reference field. Thus, as one of ordinary skill inthe art would know, a typical OR has a large number of devices (e.g., anoperating table, LCD displays, lighting equipment, imaging systems,surgical instruments, etc.) that may cause interference. Furthermore,field distortions are notoriously difficult to detect. The use ofmultiple EM sensors enables the system to detect field distortionsaccurately, and/or to warn a user that the current position measurementsmay not be accurate. Because the sensors are rigidly fixed to the bonyanatomy (e.g., via the pin/needle), relative measurement of sensorpositions (X, Y, Z) may be used to detect field distortions. By way ofnon-limiting example, in some embodiments, after the EM sensors arefixed to the bone, the relative distance between the two sensors isknown and should remain constant. Thus, any change in this distancecould indicate the presence of a field distortion.

In some embodiments, specific objects can be manually registered by asurgeon with the system preoperatively or intraoperatively. For example,by interacting with a user interface, a surgeon may identify thestarting location for a tool or a bone structure. By tracking fiducialmarks associated with that tool or bone structure, or by using otherconventional image tracking modalities, a processor may track that toolor bone as it moves through the environment in a three-dimensionalmodel.

In some embodiments, certain markers, such as fiducial marks thatidentify individuals, important tools, or bones in the theater mayinclude passive or active identifiers that can be picked up by a cameraor camera array associated with the tracking system. For example, an IRLED can flash a pattern that conveys a unique identifier to the sourceof that pattern, providing a dynamic identification mark. Similarly, oneor two dimensional optical codes (barcode, QR code, etc.) can be affixedto objects in the theater to provide passive identification that canoccur based on image analysis. If these codes are placed asymmetricallyon an object, they can also be used to determine an orientation of anobject by comparing the location of the identifier with the extents ofan object in an image. For example, a QR code may be placed in a cornerof a tool tray, allowing the orientation and identity of that tray to betracked. Other tracking modalities are explained throughout. Forexample, in some embodiments, augmented reality headsets can be worn bysurgeons and other staff to provide additional camera angles andtracking capabilities.

In addition to optical tracking, certain features of objects can betracked by registering physical properties of the object and associatingthem with objects that can be tracked, such as fiducial marks fixed to atool or bone. For example, a surgeon may perform a manual registrationprocess whereby a tracked tool and a tracked bone can be manipulatedrelative to one another. By impinging the tip of the tool against thesurface of the bone, a three-dimensional surface can be mapped for thatbone that is associated with a position and orientation relative to theframe of reference of that fiducial mark. By optically tracking theposition and orientation (pose) of the fiducial mark associated withthat bone, a model of that surface can be tracked with an environmentthrough extrapolation.

The registration process that registers the CASS 100 to the relevantanatomy of the patient can also involve the use of anatomical landmarks,such as landmarks on a bone or cartilage. For example, the CASS 100 caninclude a 3D model of the relevant bone or joint and the surgeon canintraoperatively collect data regarding the location of bony landmarkson the patient's actual bone using a probe that is connected to theCASS. Bony landmarks can include, for example, the medial malleolus andlateral malleolus, the ends of the proximal femur and distal tibia, andthe center of the hip joint. The CASS 100 can compare and register thelocation data of bony landmarks collected by the surgeon with the probewith the location data of the same landmarks in the 3D model.Alternatively, the CASS 100 can construct a 3D model of the bone orjoint without pre-operative image data by using location data of bonylandmarks and the bone surface that are collected by the surgeon using aCASS probe or other means. The registration process can also includedetermining various axes of a joint. For example, for a TKA the surgeoncan use the CASS 100 to determine the anatomical and mechanical axes ofthe femur and tibia. The surgeon and the CASS 100 can identify thecenter of the hip joint by moving the patient's leg in a spiraldirection (i.e., circumduction) so the CASS can determine where thecenter of the hip joint is located.

A Tissue Navigation System 120 (not shown in FIG. 1) provides thesurgeon with intraoperative, real-time visualization for the patient'sbone, cartilage, muscle, nervous, and/or vascular tissues surroundingthe surgical area. Examples of systems that may be employed for tissuenavigation include fluorescent imaging systems and ultrasound systems.

The Display 125 provides graphical user interfaces (GUIs) that displayimages collected by the Tissue Navigation System 120 as well otherinformation relevant to the surgery. For example, in one embodiment, theDisplay 125 overlays image information collected from various modalities(e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collectedpre-operatively or intra-operatively to give the surgeon various viewsof the patient's anatomy as well as real-time conditions. The Display125 may include, for example, one or more computer monitors. As analternative or supplement to the Display 125, one or more members of thesurgical staff may wear an Augmented Reality (AR) Head Mounted Device(HMD). For example, in FIG. 1 the Surgeon 111 is wearing an AR HMD 155that may, for example, overlay pre-operative image data on the patientor provide surgical planning suggestions. Various example uses of the ARHMD 155 in surgical procedures are detailed in the sections that follow.

Surgical Computer 150 provides control instructions to variouscomponents of the CASS 100, collects data from those components, andprovides general processing for various data needed during surgery. Insome embodiments, the Surgical Computer 150 is a general purposecomputer. In other embodiments, the Surgical Computer 150 may be aparallel computing platform that uses multiple central processing units(CPUs) or graphics processing units (GPU) to perform processing. In someembodiments, the Surgical Computer 150 is connected to a remote serverover one or more computer networks (e.g., the Internet). The remoteserver can be used, for example, for storage of data or execution ofcomputationally intensive processing tasks.

Various techniques generally known in the art can be used for connectingthe Surgical Computer 150 to the other components of the CASS 100.Moreover, the computers can connect to the Surgical Computer 150 using amix of technologies. For example, the End Effector 105B may connect tothe Surgical Computer 150 over a wired (i.e., serial) connection. TheTracking System 115, Tissue Navigation System 120, and Display 125 cansimilarly be connected to the Surgical Computer 150 using wiredconnections. Alternatively, the Tracking System 115, Tissue NavigationSystem 120, and Display 125 may connect to the Surgical Computer 150using wireless technologies such as, without limitation, Wi-Fi,Bluetooth, Near Field Communication (NFC), or ZigBee.

Powered Impaction and Acetabular Reamer Devices

Part of the flexibility of the CASS design described above with respectto FIG. 1 is that additional or alternative devices can be added to theCASS 100 as necessary to support particular surgical procedures. Forexample, in the context of hip surgeries, the CASS 100 may include apowered impaction device. Impaction devices are designed to repeatedlyapply an impaction force that the surgeon can use to perform activitiessuch as implant alignment. For example, within a total hip arthroplasty(THA), a surgeon will often insert a prosthetic acetabular cup into theimplant host's acetabulum using an impaction device. Although impactiondevices can be manual in nature (e.g., operated by the surgeon strikingan impactor with a mallet), powered impaction devices are generallyeasier and quicker to use in the surgical setting. Powered impactiondevices may be powered, for example, using a battery attached to thedevice. Various attachment pieces may be connected to the poweredimpaction device to allow the impaction force to be directed in variousways as needed during surgery. Also in the context of hip surgeries, theCASS 100 may include a powered, robotically controlled end effector toream the acetabulum to accommodate an acetabular cup implant.

In a robotically-assisted THA, the patient's anatomy can be registeredto the CASS 100 using CT or other image data, the identification ofanatomical landmarks, tracker arrays attached to the patient's bones,and one or more cameras. Tracker arrays can be mounted on the iliaccrest using clamps and/or bone pins and such trackers can be mountedexternally through the skin or internally (either posterolaterally oranterolaterally) through the incision made to perform the THA. For aTHA, the CASS 100 can utilize one or more femoral cortical screwsinserted into the proximal femur as checkpoints to aid in theregistration process. The CASS 100 can also utilize one or morecheckpoint screws inserted into the pelvis as additional checkpoints toaid in the registration process. Femoral tracker arrays can be securedto or mounted in the femoral cortical screws. The CASS 100 can employsteps where the registration is verified using a probe that the surgeonprecisely places on key areas of the proximal femur and pelvisidentified for the surgeon on the display 125. Trackers can be locatedon the robotic arm 105A or end effector 105B to register the arm and/orend effector to the CASS 100. The verification step can also utilizeproximal and distal femoral checkpoints. The CASS 100 can utilize colorprompts or other prompts to inform the surgeon that the registrationprocess for the relevant bones and the robotic arm 105A or end effector105B has been verified to a certain degree of accuracy (e.g., within 1mm).

For a THA, the CASS 100 can include a broach tracking option usingfemoral arrays to allow the surgeon to intraoperatively capture thebroach position and orientation and calculate hip length and offsetvalues for the patient. Based on information provided about thepatient's hip joint and the planned implant position and orientationafter broach tracking is completed, the surgeon can make modificationsor adjustments to the surgical plan.

For a robotically-assisted THA, the CASS 100 can include one or morepowered reamers connected or attached to a robotic arm 105A or endeffector 105B that prepares the pelvic bone to receive an acetabularimplant according to a surgical plan. The robotic arm 105A and/or endeffector 105B can inform the surgeon and/or control the power of thereamer to ensure that the acetabulum is being resected (reamed) inaccordance with the surgical plan. For example, if the surgeon attemptsto resect bone outside of the boundary of the bone to be resected inaccordance with the surgical plan, the CASS 100 can power off the reameror instruct the surgeon to power off the reamer. The CASS 100 canprovide the surgeon with an option to turn off or disengage the roboticcontrol of the reamer. The display 125 can depict the progress of thebone being resected (reamed) as compared to the surgical plan usingdifferent colors. The surgeon can view the display of the bone beingresected (reamed) to guide the reamer to complete the reaming inaccordance with the surgical plan. The CASS 100 can provide visual oraudible prompts to the surgeon to warn the surgeon that resections arebeing made that are not in accordance with the surgical plan.

Following reaming, the CASS 100 can employ a manual or powered impactorthat is attached or connected to the robotic arm 105A or end effector105B to impact trial implants and final implants into the acetabulum.The robotic arm 105A and/or end effector 105B can be used to guide theimpactor to impact the trial and final implants into the acetabulum inaccordance with the surgical plan. The CASS 100 can cause the positionand orientation of the trial and final implants vis-à-vis the bone to bedisplayed to inform the surgeon as to how the trial and final implant'sorientation and position compare to the surgical plan, and the display125 can show the implant's position and orientation as the surgeonmanipulates the leg and hip. The CASS 100 can provide the surgeon withthe option of re-planning and re-doing the reaming and implant impactionby preparing a new surgical plan if the surgeon is not satisfied withthe original implant position and orientation.

Preoperatively, the CASS 100 can develop a proposed surgical plan basedon a three dimensional model of the hip joint and other informationspecific to the patient, such as the mechanical and anatomical axes ofthe leg bones, the epicondylar axis, the femoral neck axis, thedimensions (e.g., length) of the femur and hip, the midline axis of thehip joint, the ASIS axis of the hip joint, and the location ofanatomical landmarks such as the lesser trochanter landmarks, the distallandmark, and the center of rotation of the hip joint. TheCASS-developed surgical plan can provide a recommended optimal implantsize and implant position and orientation based on the three dimensionalmodel of the hip joint and other information specific to the patient.The CASS-developed surgical plan can include proposed details on offsetvalues, inclination and anteversion values, center of rotation, cupsize, medialization values, superior-inferior fit values, femoral stemsizing and length.

For a THA, the CASS-developed surgical plan can be viewed preoperativelyand intraoperatively, and the surgeon can modify CASS-developed surgicalplan preoperatively or intraoperatively. The CASS-developed surgicalplan can display the planned resection to the hip joint and superimposethe planned implants onto the hip joint based on the planned resections.The CASS 100 can provide the surgeon with options for different surgicalworkflows that will be displayed to the surgeon based on a surgeon'spreference. For example, the surgeon can choose from different workflowsbased on the number and types of anatomical landmarks that are checkedand captured and/or the location and number of tracker arrays used inthe registration process.

According to some embodiments, a powered impaction device used with theCASS 100 may operate with a variety of different settings. In someembodiments, the surgeon adjusts settings through a manual switch orother physical mechanism on the powered impaction device. In otherembodiments, a digital interface may be used that allows setting entry,for example, via a touchscreen on the powered impaction device. Such adigital interface may allow the available settings to vary based, forexample, on the type of attachment piece connected to the powerattachment device. In some embodiments, rather than adjusting thesettings on the powered impaction device itself, the settings can bechanged through communication with a robot or other computer systemwithin the CASS 100. Such connections may be established using, forexample, a Bluetooth or Wi-Fi networking module on the powered impactiondevice. In another embodiment, the impaction device and end pieces maycontain features that allow the impaction device to be aware of what endpiece (cup impactor, broach handle, etc.) is attached with no actionrequired by the surgeon, and adjust the settings accordingly. This maybe achieved, for example, through a QR code, barcode, RFID tag, or othermethod. In some embodiments, the powered impactor device may have a dualfunction. For example, the powered impactor device not only couldprovide reciprocating motion to provide an impact force, but also couldprovide reciprocating motion for a broach or rasp.

Examples of the settings that may be used include cup impaction settings(e.g., single direction, specified frequency range, specified forceand/or energy range); broach impaction settings (e.g., dualdirection/oscillating at a specified frequency range, specified forceand/or energy range); femoral head impaction settings (e.g., singledirection/single blow at a specified force or energy); and stemimpaction settings (e.g., single direction at specified frequency with aspecified force or energy). Additionally, in some embodiments, thepowered impaction device includes settings related to acetabular linerimpaction (e.g., single direction/single blow at a specified force orenergy). There may be a plurality of settings for each type of linersuch as poly, ceramic, oxinium, or other materials. Furthermore, thepowered impaction device may offer settings for different bone qualitybased on preoperative testing/imaging/knowledge and/or intraoperativeassessment by surgeon.

In some embodiments, the powered impaction device includes feedbacksensors that gather data during instrument use, and send data to acomputing device such as a controller within the device or the SurgicalComputer 150. This computing device can then record the data for lateranalysis and use. Examples of the data that may be collected include,without limitation, sound waves, the predetermined resonance frequencyof each instrument, reaction force or rebound energy from patient bone,location of the device with respect to imaging (e.g., fluoro, CT,ultrasound, MRI, etc.) registered bony anatomy, and/or external straingauges on bones.

Once the data is collected, the computing device may execute one or morealgorithms in real-time or near real-time to aid the surgeon inperforming the surgical procedure. For example, in some embodiments, thecomputing device uses the collected data to derive information such asthe proper final broach size (femur); when the stem is fully seated(femur side); or when the cup is seated (depth and/or orientation) for aTHA. Once the information is known, it may be displayed for thesurgeon's review, or it may be used to activate haptics or otherfeedback mechanisms to guide the surgical procedure.

Additionally, the data derived from the aforementioned algorithms may beused to drive operation of the device. For example, during insertion ofa prosthetic acetabular cup with a powered impaction device, the devicemay automatically extend an impaction head (e.g., an end effector)moving the implant into the proper location, or turn the power off tothe device once the implant is fully seated. In one embodiment, thederived information may be used to automatically adjust settings forquality of bone where the powered impaction device should use less powerto mitigate femoral/acetabular/pelvic fracture or damage to surroundingtissues.

Robotic Arm

In some embodiments, the CASS 100 includes a robotic arm 105A thatserves as an interface to stabilize and hold a variety of instrumentsused during the surgical procedure. For example, in the context of a hipsurgery, these instruments may include, without limitation, retractors,a sagittal or reciprocating saw, the reamer handle, the cup impactor,the broach handle, and the stem inserter. The robotic arm 105A may havemultiple degrees of freedom (like a Spider device), and have the abilityto be locked in place (e.g., by a press of a button, voice activation, asurgeon removing a hand from the robotic arm, or other method).

In some embodiments, movement of the robotic arm 105A may be effectuatedby use of a control panel built into the robotic arm system. Forexample, a display screen may include one or more input sources, such asphysical buttons or a user interface having one or more icons, thatdirect movement of the robotic arm 105A. The surgeon or other healthcareprofessional may engage with the one or more input sources to positionthe robotic arm 105A when performing a surgical procedure.

A tool or an end effector 105B attached or integrated into a robotic arm105A may include, without limitation, a burring device, a scalpel, acutting device, a retractor, a joint tensioning device, or the like. Inembodiments in which an end effector 105B is used, the end effector maybe positioned at the end of the robotic arm 105A such that any motorcontrol operations are performed within the robotic arm system. Inembodiments in which a tool is used, the tool may be secured at a distalend of the robotic arm 105A, but motor control operation may residewithin the tool itself.

The robotic arm 105A may be motorized internally to both stabilize therobotic arm, thereby preventing it from falling and hitting the patient,surgical table, surgical staff, etc., and to allow the surgeon to movethe robotic arm without having to fully support its weight. While thesurgeon is moving the robotic arm 105A, the robotic arm may provide someresistance to prevent the robotic arm from moving too fast or having toomany degrees of freedom active at once. The position and the lock statusof the robotic arm 105A may be tracked, for example, by a controller orthe Surgical Computer 150.

In some embodiments, the robotic arm 105A can be moved by hand (e.g., bythe surgeon) or with internal motors into its ideal position andorientation for the task being performed. In some embodiments, therobotic arm 105A may be enabled to operate in a “free” mode that allowsthe surgeon to position the arm into a desired position without beingrestricted. While in the free mode, the position and orientation of therobotic arm 105A may still be tracked as described above. In oneembodiment, certain degrees of freedom can be selectively released uponinput from user (e.g., surgeon) during specified portions of thesurgical plan tracked by the Surgical Computer 150. Designs in which arobotic arm 105A is internally powered through hydraulics or motors orprovides resistance to external manual motion through similar means canbe described as powered robotic arms, while arms that are manuallymanipulated without power feedback, but which may be manually orautomatically locked in place, may be described as passive robotic arms.

A robotic arm 105A or end effector 105B can include a trigger or othermeans to control the power of a saw or drill. Engagement of the triggeror other means by the surgeon can cause the robotic arm 105A or endeffector 105B to transition from a motorized alignment mode to a modewhere the saw or drill is engaged and powered on. Additionally, the CASS100 can include a foot pedal (not shown) that causes the system toperform certain functions when activated. For example, the surgeon canactivate the foot pedal to instruct the CASS 100 to place the roboticarm 105A or end effector 105B in an automatic mode that brings therobotic arm or end effector into the proper position with respect to thepatient's anatomy in order to perform the necessary resections. The CASS100 can also place the robotic arm 105A or end effector 105B in acollaborative mode that allows the surgeon to manually manipulate andposition the robotic arm or end effector into a particular location. Thecollaborative mode can be configured to allow the surgeon to move therobotic arm 105A or end effector 105B medially or laterally, whilerestricting movement in other directions. As discussed, the robotic arm105A or end effector 105B can include a cutting device (saw, drill, andburr) or a cutting guide or jig 105D that will guide a cutting device.In other embodiments, movement of the robotic arm 105A or roboticallycontrolled end effector 105B can be controlled entirely by the CASS 100without any, or with only minimal, assistance or input from a surgeon orother medical professional. In still other embodiments, the movement ofthe robotic arm 105A or robotically controlled end effector 105B can becontrolled remotely by a surgeon or other medical professional using acontrol mechanism separate from the robotic arm or roboticallycontrolled end effector device, for example using a joystick orinteractive monitor or display control device.

The examples below describe uses of the robotic device in the context ofa hip surgery; however, it should be understood that the robotic arm mayhave other applications for surgical procedures involving knees,shoulders, etc. One example of use of a robotic arm in the context offorming an anterior cruciate ligament (ACL) graft tunnel is described inU.S. Provisional Patent Application No. 62/723,898 filed Aug. 28, 2018and entitled “Robotic Assisted Ligament Graft Placement and Tensioning,”the entirety of which is incorporated herein by reference.

A robotic arm 105A may be used for holding the retractor. For example inone embodiment, the robotic arm 105A may be moved into the desiredposition by the surgeon. At that point, the robotic arm 105A may lockinto place. In some embodiments, the robotic arm 105A is provided withdata regarding the patient's position, such that if the patient moves,the robotic arm can adjust the retractor position accordingly. In someembodiments, multiple robotic arms may be used, thereby allowingmultiple retractors to be held or for more than one activity to beperformed simultaneously (e.g., retractor holding & reaming).

The robotic arm 105A may also be used to help stabilize the surgeon'shand while making a femoral neck cut. In this application, control ofthe robotic arm 105A may impose certain restrictions to prevent softtissue damage from occurring. For example, in one embodiment, theSurgical Computer 150 tracks the position of the robotic arm 105A as itoperates. If the tracked location approaches an area where tissue damageis predicted, a command may be sent to the robotic arm 105A causing itto stop. Alternatively, where the robotic arm 105A is automaticallycontrolled by the Surgical Computer 150, the Surgical Computer mayensure that the robotic arm is not provided with any instructions thatcause it to enter areas where soft tissue damage is likely to occur. TheSurgical Computer 150 may impose certain restrictions on the surgeon toprevent the surgeon from reaming too far into the medial wall of theacetabulum or reaming at an incorrect angle or orientation.

In some embodiments, the robotic arm 105A may be used to hold a cupimpactor at a desired angle or orientation during cup impaction. Whenthe final position has been achieved, the robotic arm 105A may preventany further seating to prevent damage to the pelvis.

The surgeon may use the robotic arm 105A to position the broach handleat the desired position and allow the surgeon to impact the broach intothe femoral canal at the desired orientation. In some embodiments, oncethe Surgical Computer 150 receives feedback that the broach is fullyseated, the robotic arm 105A may restrict the handle to prevent furtheradvancement of the broach.

The robotic arm 105A may also be used for resurfacing applications. Forexample, the robotic arm 105A may stabilize the surgeon while usingtraditional instrumentation and provide certain restrictions orlimitations to allow for proper placement of implant components (e.g.,guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.).Where only a burr is employed, the robotic arm 105A may stabilize thesurgeon's handpiece and may impose restrictions on the handpiece toprevent the surgeon from removing unintended bone in contravention ofthe surgical plan.

The robotic arm 105A may be a passive arm. As an example, the roboticarm 105A may be a CIRQ robot arm available from Brainlab AG. CIRQ is aregistered trademark of Brainlab AG, Olof-Palme-Str. 9 81829, München,FED REP of GERMANY. In one particular embodiment, the robotic arm 105Ais an intelligent holding arm as disclosed in U.S. patent applicationSer. No. 15/525,585 to Krinninger et al., U.S. patent application Ser.No. 15/561,042 to Nowatschin et al., U.S. patent application Ser. No.15/561,048 to Nowatschin et al., and U.S. Pat. No. 10,342,636 toNowatschin et al., the entire contents of each of which is hereinincorporated by reference.

Surgical Procedure Data Generation and Collection

The various services that are provided by medical professionals to treata clinical condition are collectively referred to as an “episode ofcare.” For a particular surgical intervention the episode of care caninclude three phases: pre-operative, intra-operative, andpost-operative. During each phase, data is collected or generated thatcan be used to analyze the episode of care in order to understandvarious aspects of the procedure and identify patterns that may be used,for example, in training models to make decisions with minimal humanintervention. The data collected over the episode of care may be storedat the Surgical Computer 150 or the Surgical Data Server 180 as acomplete dataset. Thus, for each episode of care, a dataset exists thatcomprises all of the data collectively pre-operatively about thepatient, all of the data collected or stored by the CASS 100intra-operatively, and any post-operative data provided by the patientor by a healthcare professional monitoring the patient.

As explained in further detail, the data collected during the episode ofcare may be used to enhance performance of the surgical procedure or toprovide a holistic understanding of the surgical procedure and thepatient outcomes. For example, in some embodiments, the data collectedover the episode of care may be used to generate a surgical plan. In oneembodiment, a high-level, pre-operative plan is refinedintra-operatively as data is collected during surgery. In this way, thesurgical plan can be viewed as dynamically changing in real-time or nearreal-time as new data is collected by the components of the CASS 100. Inother embodiments, pre-operative images or other input data may be usedto develop a robust plan preoperatively that is simply executed duringsurgery. In this case, the data collected by the CASS 100 during surgerymay be used to make recommendations that ensure that the surgeon stayswithin the pre-operative surgical plan. For example, if the surgeon isunsure how to achieve a certain prescribed cut or implant alignment, theSurgical Computer 150 can be queried for a recommendation. In stillother embodiments, the pre-operative and intra-operative planningapproaches can be combined such that a robust pre-operative plan can bedynamically modified, as necessary or desired, during the surgicalprocedure. In some embodiments, a biomechanics-based model of patientanatomy contributes simulation data to be considered by the CASS 100 indeveloping preoperative, intraoperative, andpost-operative/rehabilitation procedures to optimize implant performanceoutcomes for the patient.

Aside from changing the surgical procedure itself, the data gatheredduring the episode of care may be used as an input to other proceduresancillary to the surgery. For example, in some embodiments, implants canbe designed using episode of care data. Example data-driven techniquesfor designing, sizing, and fitting implants are described in U.S. patentapplication Ser. No. 13/814,531 filed Aug. 15, 2011 and entitled“Systems and Methods for Optimizing Parameters for OrthopaedicProcedures”; U.S. patent application Ser. No. 14/232,958 filed Jul. 20,2012 and entitled “Systems and Methods for Optimizing Fit of an Implantto Anatomy”; and U.S. patent application Ser. No. 12/234,444 filed Sep.19, 2008 and entitled “Operatively Tuning Implants for IncreasedPerformance,” the entire contents of each of which are herebyincorporated by reference into this patent application.

Furthermore, the data can be used for educational, training, or researchpurposes. For example, using the network-based approach described belowin FIG. 5C, other doctors or students can remotely view surgeries ininterfaces that allow them to selectively view data as it is collectedfrom the various components of the CASS 100. After the surgicalprocedure, similar interfaces may be used to “playback” a surgery fortraining or other educational purposes, or to identify the source of anyissues or complications with the procedure.

Data acquired during the pre-operative phase generally includes allinformation collected or generated prior to the surgery. Thus, forexample, information about the patient may be acquired from a patientintake form or electronic medical record (EMR). Examples of patientinformation that may be collected include, without limitation, patientdemographics, diagnoses, medical histories, progress notes, vital signs,medical history information, allergies, and lab results. Thepre-operative data may also include images related to the anatomicalarea of interest. These images may be captured, for example, usingMagnetic Resonance Imaging (MRI), Computed Tomography (CT), X-ray,ultrasound, or any other modality known in the art. The pre-operativedata may also comprise quality of life data captured from the patient.For example, in one embodiment, pre-surgery patients use a mobileapplication (“app”) to answer questionnaires regarding their currentquality of life. In some embodiments, preoperative data used by the CASS100 includes demographic, anthropometric, cultural, or other specifictraits about a patient that can coincide with activity levels andspecific patient activities to customize the surgical plan to thepatient. For example, certain cultures or demographics may be morelikely to use a toilet that requires squatting on a daily basis.

FIGS. 5A and 5B provide examples of data that may be acquired during theintra-operative phase of an episode of care. These examples are based onthe various components of the CASS 100 described above with reference toFIG. 1; however, it should be understood that other types of data may beused based on the types of equipment used during surgery and their use.

FIG. 5A shows examples of some of the control instructions that theSurgical Computer 150 provides to other components of the CASS 100,according to some embodiments. Note that the example of FIG. 5A assumesthat the components of the Effector Platform 105 are each controlleddirectly by the Surgical Computer 150. In embodiments where a componentis manually controlled by the Surgeon 111, instructions may be providedon the Display 125 or AR HMD 155 instructing the Surgeon 111 how to movethe component.

The various components included in the Effector Platform 105 arecontrolled by the Surgical Computer 150 providing position commands thatinstruct the component where to move within a coordinate system. In someembodiments, the Surgical Computer 150 provides the Effector Platform105 with instructions defining how to react when a component of theEffector Platform 105 deviates from a surgical plan. These commands arereferenced in FIG. 5A as “haptic” commands. For example, the EndEffector 105B may provide a force to resist movement outside of an areawhere resection is planned. Other commands that may be used by theEffector Platform 105 include vibration and audio cues.

In some embodiments, the end effectors 105B of the robotic arm 105A areoperatively coupled with cutting guide 105D. In response to ananatomical model of the surgical scene, the robotic arm 105A can movethe end effectors 105B and the cutting guide 105D into position to matchthe location of the femoral or tibial cut to be performed in accordancewith the surgical plan. This can reduce the likelihood of error,allowing the vision system and a processor utilizing that vision systemto implement the surgical plan to place a cutting guide 105D at theprecise location and orientation relative to the tibia or femur to aligna cutting slot of the cutting guide with the cut to be performedaccording to the surgical plan. Then, a surgeon can use any suitabletool, such as an oscillating or rotating saw or drill to perform the cut(or drill a hole) with perfect placement and orientation because thetool is mechanically limited by the features of the cutting guide 105D.In some embodiments, the cutting guide 105D may include one or more pinholes that are used by a surgeon to drill and screw or pin the cuttingguide into place before performing a resection of the patient tissueusing the cutting guide. This can free the robotic arm 105A or ensurethat the cutting guide 105D is fully affixed without moving relative tothe bone to be resected. For example, this procedure can be used to makethe first distal cut of the femur during a total knee arthroplasty. Insome embodiments, where the arthroplasty is a hip arthroplasty, cuttingguide 105D can be fixed to the femoral head or the acetabulum for therespective hip arthroplasty resection. It should be understood that anyarthroplasty that utilizes precise cuts can use the robotic arm 105Aand/or cutting guide 105D in this manner.

The Resection Equipment 110 is provided with a variety of commands toperform bone or tissue operations. As with the Effector Platform 105,position information may be provided to the Resection Equipment 110 tospecify where it should be located when performing resection. Othercommands provided to the Resection Equipment 110 may be dependent on thetype of resection equipment. For example, for a mechanical or ultrasonicresection tool, the commands may specify the speed and frequency of thetool. For Radiofrequency Ablation (RFA) and other laser ablation tools,the commands may specify intensity and pulse duration.

Some components of the CASS 100 do not need to be directly controlled bythe Surgical Computer 150; rather, the Surgical Computer 150 only needsto activate the component, which then executes software locallyspecifying the manner in which to collect data and provide it to theSurgical Computer 150. In the example of FIG. 5A, there are twocomponents that are operated in this manner: the Tracking System 115 andthe Tissue Navigation System 120.

The Surgical Computer 150 provides the Display 125 with anyvisualization that is needed by the Surgeon 111 during surgery. Formonitors, the Surgical Computer 150 may provide instructions fordisplaying images, GUIs, etc. using techniques known in the art. Thedisplay 125 can include various aspects of the workflow of a surgicalplan. During the registration process, for example, the display 125 canshow a preoperatively constructed 3D bone model and depict the locationsof the probe as the surgeon uses the probe to collect locations ofanatomical landmarks on the patient. The display 125 can includeinformation about the surgical target area. For example, in connectionwith a TKA, the display 125 can depict the mechanical and anatomicalaxes of the femur and tibia. The display 125 can depict varus and valgusangles for the knee joint based on a surgical plan, and the CASS 100 candepict how such angles will be affected if contemplated revisions to thesurgical plan are made. Accordingly, the display 125 is an interactiveinterface that can dynamically update and display how changes to thesurgical plan would impact the procedure and the final position andorientation of implants installed on bone.

As the workflow progresses to preparation of bone cuts or resections,the display 125 can depict the planned or recommended bone cuts beforeany cuts are performed. The surgeon 111 can manipulate the image displayto provide different anatomical perspectives of the target area and canhave the option to alter or revise the planned bone cuts based onintraoperative evaluation of the patient. The display 125 can depict howthe chosen implants would be installed on the bone if the planned bonecuts are performed. If the surgeon 111 choses to change the previouslyplanned bone cuts, the display 125 can depict how the revised bone cutswould change the position and orientation of the implant when installedon the bone.

The display 125 can provide the surgeon 111 with a variety of data andinformation about the patient, the planned surgical intervention, andthe implants. Various patient-specific information can be displayed,including real-time data concerning the patient's health such as heartrate, blood pressure, etc. The display 125 can also include informationabout the anatomy of the surgical target region including the locationof landmarks, the current state of the anatomy (e.g., whether anyresections have been made, the depth and angles of planned and executedbone cuts), and future states of the anatomy as the surgical planprogresses. The display 125 can also provide or depict additionalinformation about the surgical target region. For a TKA, the display 125can provide information about the gaps (e.g., gap balancing) between thefemur and tibia and how such gaps will change if the planned surgicalplan is carried out. For a TKA, the display 125 can provide additionalrelevant information about the knee joint such as data about the joint'stension (e.g., ligament laxity) and information concerning rotation andalignment of the joint. The display 125 can depict how the plannedimplants' locations and positions will affect the patient as the kneejoint is flexed. The display 125 can depict how the use of differentimplants or the use of different sizes of the same implant will affectthe surgical plan and preview how such implants will be positioned onthe bone. The CASS 100 can provide such information for each of theplanned bone resections in a TKA or THA. In a TKA, the CASS 100 canprovide robotic control for one or more of the planned bone resections.For example, the CASS 100 can provide robotic control only for theinitial distal femur cut, and the surgeon 111 can manually perform otherresections (anterior, posterior and chamfer cuts) using conventionalmeans, such as a 4-in-1 cutting guide or jig 105D.

The display 125 can employ different colors to inform the surgeon of thestatus of the surgical plan. For example, un-resected bone can bedisplayed in a first color, resected bone can be displayed in a secondcolor, and planned resections can be displayed in a third color.Implants can be superimposed onto the bone in the display 125, andimplant colors can change or correspond to different types or sizes ofimplants.

The information and options depicted on the display 125 can varydepending on the type of surgical procedure being performed. Further,the surgeon 111 can request or select a particular surgical workflowdisplay that matches or is consistent with his or her surgical planpreferences. For example, for a surgeon 111 who typically performs thetibial cuts before the femoral cuts in a TKA, the display 125 andassociated workflow can be adapted to take this preference into account.The surgeon 111 can also preselect that certain steps be included ordeleted from the standard surgical workflow display. For example, if asurgeon 111 uses resection measurements to finalize an implant plan butdoes not analyze ligament gap balancing when finalizing the implantplan, the surgical workflow display can be organized into modules, andthe surgeon can select which modules to display and the order in whichthe modules are provided based on the surgeon's preferences or thecircumstances of a particular surgery. Modules directed to ligament andgap balancing, for example, can include pre- and post-resectionligament/gap balancing, and the surgeon 111 can select which modules toinclude in their default surgical plan workflow depending on whetherthey perform such ligament and gap balancing before or after (or both)bone resections are performed.

For more specialized display equipment, such as AR HMDs, the SurgicalComputer 150 may provide images, text, etc. using the data formatsupported by the equipment. For example, if the Display 125 is aholography device such as the Microsoft HoloLens™ or Magic Leap One™,the Surgical Computer 150 may use the HoloLens Application ProgramInterface (API) to send commands specifying the position and content ofholograms displayed in the field of view of the Surgeon 111.

In some embodiments, one or more surgical planning models may beincorporated into the CASS 100 and used in the development of thesurgical plans provided to the surgeon 111. The term “surgical planningmodel” refers to software that simulates the biomechanics performance ofanatomy under various scenarios to determine the optimal way to performcutting and other surgical activities. For example, for knee replacementsurgeries, the surgical planning model can measure parameters forfunctional activities, such as deep knee bends, gait, etc., and selectcut locations on the knee to optimize implant placement. One example ofa surgical planning model is the LIFEMOD™ simulation software from SMITHAND NEPHEW, INC. In some embodiments, the Surgical Computer 150 includescomputing architecture that allows full execution of the surgicalplanning model during surgery (e.g., a GPU-based parallel processingenvironment). In other embodiments, the Surgical Computer 150 may beconnected over a network to a remote computer that allows suchexecution, such as a Surgical Data Server 180 (see FIG. 5C). As analternative to full execution of the surgical planning model, in someembodiments, a set of transfer functions are derived that simplify themathematical operations captured by the model into one or more predictorequations. Then, rather than execute the full simulation during surgery,the predictor equations are used. Further details on the use of transferfunctions are described in U.S. Provisional Patent Application No.62/719,415 entitled “Patient Specific Surgical Method and System,” theentirety of which is incorporated herein by reference.

FIG. 5B shows examples of some of the types of data that can be providedto the Surgical Computer 150 from the various components of the CASS100. In some embodiments, the components may stream data to the SurgicalComputer 150 in real-time or near real-time during surgery. In otherembodiments, the components may queue data and send it to the SurgicalComputer 150 at set intervals (e.g., every second). Data may becommunicated using any format known in the art. Thus, in someembodiments, the components all transmit data to the Surgical Computer150 in a common format. In other embodiments, each component may use adifferent data format, and the Surgical Computer 150 is configured withone or more software applications that enable translation of the data.

In general, the Surgical Computer 150 may serve as the central pointwhere CASS data is collected. The exact content of the data will varydepending on the source. For example, each component of the EffectorPlatform 105 provides a measured position to the Surgical Computer 150.Thus, by comparing the measured position to a position originallyspecified by the Surgical Computer 150 (see FIG. 5B), the SurgicalComputer can identify deviations that take place during surgery.

The Resection Equipment 110 can send various types of data to theSurgical Computer 150 depending on the type of equipment used. Exampledata types that may be sent include the measured torque, audiosignatures, and measured displacement values. Similarly, the TrackingTechnology 115 can provide different types of data depending on thetracking methodology employed. Example tracking data types includeposition values for tracked items (e.g., anatomy, tools, etc.),ultrasound images, and surface or landmark collection points or axes.The Tissue Navigation System 120 provides the Surgical Computer 150 withanatomic locations, shapes, etc. as the system operates.

Although the Display 125 generally is used for outputting data forpresentation to the user, it may also provide data to the SurgicalComputer 150. For example, for embodiments where a monitor is used aspart of the Display 125, the Surgeon 111 may interact with a GUI toprovide inputs which are sent to the Surgical Computer 150 for furtherprocessing. For AR applications, the measured position and displacementof the HMD may be sent to the Surgical Computer 150 so that it canupdate the presented view as needed.

During the post-operative phase of the episode of care, various types ofdata can be collected to quantify the overall improvement ordeterioration in the patient's condition as a result of the surgery. Thedata can take the form of, for example, self-reported informationreported by patients via questionnaires. For example, in the context ofa knee replacement surgery, functional status can be measured with anOxford Knee Score questionnaire, and the post-operative quality of lifecan be measured with a EQ5D-5L questionnaire. Other examples in thecontext of a hip replacement surgery may include the Oxford Hip Score,Harris Hip Score, and WOMAC (Western Ontario and McMaster UniversitiesOsteoarthritis index). Such questionnaires can be administered, forexample, by a healthcare professional directly in a clinical setting orusing a mobile app that allows the patient to respond to questionsdirectly. In some embodiments, the patient may be outfitted with one ormore wearable devices that collect data relevant to the surgery. Forexample, following a knee surgery, the patient may be outfitted with aknee brace that includes sensors that monitor knee positioning,flexibility, etc. This information can be collected and transferred tothe patient's mobile device for review by the surgeon to evaluate theoutcome of the surgery and address any issues. In some embodiments, oneor more cameras can capture and record the motion of a patient's bodysegments during specified activities postoperatively. This motioncapture can be compared to a biomechanics model to better understand thefunctionality of the patient's joints and better predict progress inrecovery and identify any possible revisions that may be needed.

The post-operative stage of the episode of care can continue over theentire life of a patient. For example, in some embodiments, the SurgicalComputer 150 or other components comprising the CASS 100 can continue toreceive and collect data relevant to a surgical procedure after theprocedure has been performed. This data may include, for example,images, answers to questions, “normal” patient data (e.g., blood type,blood pressure, conditions, medications, etc.), biometric data (e.g.,gait, etc.), and objective and subjective data about specific issues(e.g., knee or hip joint pain). This data may be explicitly provided tothe Surgical Computer 150 or other CASS component by the patient or thepatient's physician(s). Alternatively or additionally, the SurgicalComputer 150 or other CASS component can monitor the patient's EMR andretrieve relevant information as it becomes available. This longitudinalview of the patient's recovery allows the Surgical Computer 150 or otherCASS component to provide a more objective analysis of the patient'soutcome to measure and track success or lack of success for a givenprocedure. For example, a condition experienced by a patient long afterthe surgical procedure can be linked back to the surgery through aregression analysis of various data items collected during the episodeof care. This analysis can be further enhanced by performing theanalysis on groups of patients that had similar procedures and/or havesimilar anatomies.

In some embodiments, data is collected at a central location to providefor easier analysis and use. Data can be manually collected from variousCASS components in some instances. For example, a portable storagedevice (e.g., USB stick) can be attached to the Surgical Computer 150into order to retrieve data collected during surgery. The data can thenbe transferred, for example, via a desktop computer to the centralizedstorage. Alternatively, in some embodiments, the Surgical Computer 150is connected directly to the centralized storage via a Network 175 asshown in FIG. 5C.

FIG. 5C illustrates a “cloud-based” implementation in which the SurgicalComputer 150 is connected to a Surgical Data Server 180 via a Network175. This Network 175 may be, for example, a private intranet or theInternet. In addition to the data from the Surgical Computer 150, othersources can transfer relevant data to the Surgical Data Server 180. Theexample of FIG. 5C shows 3 additional data sources: the Patient 160,Healthcare Professional(s) 165, and an EMR Database 170. Thus, thePatient 160 can send pre-operative and post-operative data to theSurgical Data Server 180, for example, using a mobile app. TheHealthcare Professional(s) 165 includes the surgeon and his or her staffas well as any other professionals working with Patient 160 (e.g., apersonal physician, a rehabilitation specialist, etc.). It should alsobe noted that the EMR Database 170 may be used for both pre-operativeand post-operative data. For example, assuming that the Patient 160 hasgiven adequate permissions, the Surgical Data Server 180 may collect theEMR of the Patient pre-surgery. Then, the Surgical Data Server 180 maycontinue to monitor the EMR for any updates post-surgery.

At the Surgical Data Server 180, an Episode of Care Database 185 is usedto store the various data collected over a patient's episode of care.The Episode of Care Database 185 may be implemented using any techniqueknown in the art. For example, in some embodiments, a SQL-based databasemay be used where all of the various data items are structured in amanner that allows them to be readily incorporated in two SQL'scollection of rows and columns. However, in other embodiments a No-SQLdatabase may be employed to allow for unstructured data, while providingthe ability to rapidly process and respond to queries. As is understoodin the art, the term “No-SQL” is used to define a class of data storesthat are non-relational in their design. Various types of No-SQLdatabases may generally be grouped according to their underlying datamodel. These groupings may include databases that use column-based datamodels (e.g., Cassandra), document-based data models (e.g., MongoDB),key-value based data models (e.g., Redis), and/or graph-based datamodels (e.g., Allego). Any type of No-SQL database may be used toimplement the various embodiments described herein and, in someembodiments, the different types of databases may support the Episode ofCare Database 185.

Data can be transferred between the various data sources and theSurgical Data Server 180 using any data format and transfer techniqueknown in the art. It should be noted that the architecture shown in FIG.5C allows transmission from the data source to the Surgical Data Server180, as well as retrieval of data from the Surgical Data Server 180 bythe data sources. For example, as explained in detail below, in someembodiments, the Surgical Computer 150 may use data from past surgeries,machine learning models, etc. to help guide the surgical procedure.

In some embodiments, the Surgical Computer 150 or the Surgical DataServer 180 may execute a de-identification process to ensure that datastored in the Episode of Care Database 185 meets Health InsurancePortability and Accountability Act (HIPAA) standards or otherrequirements mandated by law. HIPAA provides a list of certainidentifiers that must be removed from data during de-identification. Theaforementioned de-identification process can scan for these identifiersin data that is transferred to the Episode of Care Database 185 forstorage. For example, in one embodiment, the Surgical Computer 150executes the de-identification process just prior to initiating transferof a particular data item or set of data items to the Surgical DataServer 180. In some embodiments, a unique identifier is assigned to datafrom a particular episode of care to allow for re-identification of thedata if necessary.

Although FIGS. 5A-5C discuss data collection in the context of a singleepisode of care, it should be understood that the general concept can beextended to data collection from multiple episodes of care. For example,surgical data may be collected over an entire episode of care each timea surgery is performed with the CASS 100 and stored at the SurgicalComputer 150 or at the Surgical Data Server 180. As explained in furtherdetail below, a robust database of episode of care data allows thegeneration of optimized values, measurements, distances, or otherparameters and other recommendations related to the surgical procedure.In some embodiments, the various datasets are indexed in the database orother storage medium in a manner that allows for rapid retrieval ofrelevant information during the surgical procedure. For example, in oneembodiment, a patient-centric set of indices may be used so that datapertaining to a particular patient or a set of patients similar to aparticular patient can be readily extracted. This concept can besimilarly applied to surgeons, implant characteristics, CASS componentversions, etc.

Further details of the management of episode of care data is describedin U.S. Patent Application No. 62/783,858 filed Dec. 21, 2018 andentitled “Methods and Systems for Providing an Episode of Care,” theentirety of which is incorporated herein by reference.

Open Versus Closed Digital Ecosystems

In some embodiments, the CASS 100 is designed to operate as aself-contained or “closed” digital ecosystem. Each component of the CASS100 is specifically designed to be used in the closed ecosystem, anddata is generally not accessible to devices outside of the digitalecosystem. For example, in some embodiments, each component includessoftware or firmware that implements proprietary protocols foractivities such as communication, storage, security, etc. The concept ofa closed digital ecosystem may be desirable for a company that wants tocontrol all components of the CASS 100 to ensure that certaincompatibility, security, and reliability standards are met. For example,the CASS 100 can be designed such that a new component cannot be usedwith the CASS unless it is certified by the company.

In other embodiments, the CASS 100 is designed to operate as an “open”digital ecosystem. In these embodiments, components may be produced by avariety of different companies according to standards for activities,such as communication, storage, and security. Thus, by using thesestandards, any company can freely build an independent, compliantcomponent of the CASS platform. Data may be transferred betweencomponents using publicly available application programming interfaces(APIs) and open, shareable data formats.

To illustrate one type of recommendation that may be performed with theCASS 100, a technique for optimizing surgical parameters is disclosedbelow. The term “optimization” in this context means selection ofparameters that are optimal based on certain specified criteria. In anextreme case, optimization can refer to selecting optimal parameter(s)based on data from the entire episode of care, including anypre-operative data, the state of CASS data at a given point in time, andpost-operative goals. Moreover, optimization may be performed usinghistorical data, such as data generated during past surgeries involving,for example, the same surgeon, past patients with physicalcharacteristics similar to the current patient, or the like.

The optimized parameters may depend on the portion of the patient'sanatomy to be operated on. For example, for knee surgeries, the surgicalparameters may include positioning information for the femoral andtibial component including, without limitation, rotational alignment(e.g., varus/valgus rotation, external rotation, flexion rotation forthe femoral component, posterior slope of the tibial component),resection depths (e.g., varus knee, valgus knee), and implant type, sizeand position. The positioning information may further include surgicalparameters for the combined implant, such as overall limb alignment,combined tibiofemoral hyperextension, and combined tibiofemoralresection. Additional examples of parameters that could be optimized fora given TKA femoral implant by the CASS 100 include the following:

Exemplary Parameter Reference Recommendation(s) Size Posterior Thelargest sized implant that does not overhang medial/lateral bone edgesor overhang the anterior femur. A size that does not result inoverstuffing the patella femoral joint Implant Position— Medial/lateralcortical Center the implant Medial Lateral bone edges evenly between themedial/lateral cortical bone edges Resection Depth— Distal and posterior6 mm of bone Varus Knee lateral Resection Depth— Distal and posterior 7mm of bone Valgus Knee medial Rotation—Varus/Valgus Mechanical Axis 1°varus Rotation—External Transepicondylar 1° external from the Axistransepicondylar axis Rotation—Flexion Mechanical Axis 3° flexed

Additional examples of parameters that could be optimized for a givenTKA tibial implant by the CASS 100 include the following:

Exemplary Parameter Reference Recommendation(s) Size Posterior Thelargest sized implant that does not overhang the medial, lateral,anterior, and posterior tibial edges Implant Position Medial/lateral andCenter the implant anterior/posterior evenly between the cortical boneedges medial/lateral and anterior/posterior cortical bone edgesResection Depth— Lateral/Medial 4 mm of bone Varus Knee Resection Depth—Lateral/Medial 5 mm of bone Valgus Knee Rotation—Varus/Valgus MechanicalAxis 1° valgus Rotation—External Tibial Anterior 1° external from thePosterior Axis tibial anterior paxis Posterior Slope Mechanical Axis 3°posterior slope

For hip surgeries, the surgical parameters may comprise femoral neckresection location and angle, cup inclination angle, cup anteversionangle, cup depth, femoral stem design, femoral stem size, fit of thefemoral stem within the canal, femoral offset, leg length, and femoralversion of the implant.

Shoulder parameters may include, without limitation, humeral resectiondepth/angle, humeral stem version, humeral offset, glenoid version andinclination, as well as reverse shoulder parameters such as humeralresection depth/angle, humeral stem version, Glenoid tilt/version,glenosphere orientation, glenosphere offset and offset direction.

Various conventional techniques exist for optimizing surgicalparameters. However, these techniques are typically computationallyintensive and, thus, parameters often need to be determinedpre-operatively. As a result, the surgeon is limited in his or herability to make modifications to optimized parameters based on issuesthat may arise during surgery. Moreover, conventional optimizationtechniques typically operate in a “black box” manner with little or noexplanation regarding recommended parameter values. Thus, if the surgeondecides to deviate from a recommended parameter value, the surgeontypically does so without a full understanding of the effect of thatdeviation on the rest of the surgical workflow, or the impact of thedeviation on the patient's post-surgery quality of life.

Operative Patient Care System

The general concepts of optimization may be extended to the entireepisode of care using an Operative Patient Care System 620 that uses thesurgical data, and other data from the Patient 605 and HealthcareProfessionals 630 to optimize outcomes and patient satisfaction asdepicted in FIG. 6.

Conventionally, pre-operative diagnosis, pre-operative surgicalplanning, intra-operative execution of a prescribed plan, andpost-operative management of total joint arthroplasty are based onindividual experience, published literature, and training knowledgebases of surgeons (ultimately, tribal knowledge of individual surgeonsand their ‘network’ of peers and journal publications) and their nativeability to make accurate intra-operative tactile discernment of“balance” and accurate manual execution of planar resections usingguides and visual cues. This existing knowledge base and execution islimited with respect to the outcomes optimization offered to patientsneeding care. For example, limits exist with respect to accuratelydiagnosing a patient to the proper, least-invasive prescribed care;aligning dynamic patient, healthcare economic, and surgeon preferenceswith patient-desired outcomes; executing a surgical plan resulting inproper bone alignment and balance, etc.; and receiving data fromdisconnected sources having different biases that are difficult toreconcile into a holistic patient framework. Accordingly, a data-driventool that more accurately models anatomical response and guides thesurgical plan can improve the existing approach.

The Operative Patient Care System 620 is designed to utilize patientspecific data, surgeon data, healthcare facility data, and historicaloutcome data to develop an algorithm that suggests or recommends anoptimal overall treatment plan for the patient's entire episode of care(preoperative, operative, and postoperative) based on a desired clinicaloutcome. For example, in one embodiment, the Operative Patient CareSystem 620 tracks adherence to the suggested or recommended plan, andadapts the plan based on patient/care provider performance. Once thesurgical treatment plan is complete, collected data is logged by theOperative Patient Care System 620 in a historical database. Thisdatabase is accessible for future patients and the development of futuretreatment plans. In addition to utilizing statistical and mathematicalmodels, simulation tools (e.g., LIFEMOD®) can be used to simulateoutcomes, alignment, kinematics, etc. based on a preliminary or proposedsurgical plan, and reconfigure the preliminary or proposed plan toachieve desired or optimal results according to a patient's profile or asurgeon's preferences. The Operative Patient Care System 620 ensuresthat each patient is receiving personalized surgical and rehabilitativecare, thereby improving the chance of successful clinical outcomes andlessening the economic burden on the facility associated with near-termrevision.

In some embodiments, the Operative Patient Care System 620 employs adata collecting and management method to provide a detailed surgicalcase plan with distinct steps that are monitored and/or executed using aCASS 100. The performance of the user(s) is calculated at the completionof each step and can be used to suggest changes to the subsequent stepsof the case plan. Case plan generation relies on a series of input datathat is stored on a local or cloud-storage database. Input data can berelated to both the current patient undergoing treatment and historicaldata from patients who have received similar treatment(s).

A Patient 605 provides inputs such as Current Patient Data 610 andHistorical Patient Data 615 to the Operative Patient Care System 620.Various methods generally known in the art may be used to gather suchinputs from the Patient 605. For example, in some embodiments, thePatient 605 fills out a paper or digital survey that is parsed by theOperative Patient Care System 620 to extract patient data. In otherembodiments, the Operative Patient Care System 620 may extract patientdata from existing information sources, such as electronic medicalrecords (EMRs), health history files, and payer/provider historicalfiles. In still other embodiments, the Operative Patient Care System 620may provide an application program interface (API) that allows theexternal data source to push data to the Operative Patient Care System.For example, the Patient 605 may have a mobile phone, wearable device,or other mobile device that collects data (e.g., heart rate, pain ordiscomfort levels, exercise or activity levels, or patient-submittedresponses to the patient's adherence with any number of pre-operativeplan criteria or conditions) and provides that data to the OperativePatient Care System 620. Similarly, the Patient 605 may have a digitalapplication on his or her mobile or wearable device that enables data tobe collected and transmitted to the Operative Patient Care System 620.

Current Patient Data 610 can include, but is not limited to, activitylevel, preexisting conditions, comorbidities, prehab performance, healthand fitness level, pre-operative expectation level (relating tohospital, surgery, and recovery), a Metropolitan Statistical Area (MSA)driven score, genetic background, prior injuries (sports, trauma, etc.),previous joint arthroplasty, previous trauma procedures, previous sportsmedicine procedures, treatment of the contralateral joint or limb, gaitor biomechanical information (back and ankle issues), levels of pain ordiscomfort, care infrastructure information (payer coverage type, homehealth care infrastructure level, etc.), and an indication of theexpected ideal outcome of the procedure.

Historical Patient Data 615 can include, but is not limited to, activitylevel, preexisting conditions, comorbidities, prehab performance, healthand fitness level, pre-operative expectation level (relating tohospital, surgery, and recovery), a MSA driven score, geneticbackground, prior injuries (sports, trauma, etc.), previous jointarthroplasty, previous trauma procedures, previous sports medicineprocedures, treatment of the contralateral joint or limb, gait orbiomechanical information (back and ankle issues), levels or pain ordiscomfort, care infrastructure information (payer coverage type, homehealth care infrastructure level, etc.), expected ideal outcome of theprocedure, actual outcome of the procedure (patient reported outcomes[PROs], survivorship of implants, pain levels, activity levels, etc.),sizes of implants used, position/orientation/alignment of implants used,soft-tissue balance achieved, etc.

Healthcare Professional(s) 630 conducting the procedure or treatment mayprovide various types of data 625 to the Operative Patient Care System620. This Healthcare Professional Data 625 may include, for example, adescription of a known or preferred surgical technique (e.g., CruciateRetaining (CR) vs Posterior Stabilized (PS), up-vs down-sizing,tourniquet vs tourniquet-less, femoral stem style, preferred approachfor THA, etc.), the level of training of the Healthcare Professional(s)630 (e.g., years in practice, fellowship trained, where they trained,whose techniques they emulate), previous success level includinghistorical data (outcomes, patient satisfaction), and the expected idealoutcome with respect to range of motion, days of recovery, andsurvivorship of the device. The Healthcare Professional Data 625 can becaptured, for example, with paper or digital surveys provided to theHealthcare Professional 630, via inputs to a mobile application by theHealthcare Professional, or by extracting relevant data from EMRs. Inaddition, the CASS 100 may provide data such as profile data (e.g., aPatient Specific Knee Instrument Profile) or historical logs describinguse of the CASS during surgery.

Information pertaining to the facility where the procedure or treatmentwill be conducted may be included in the input data. This data caninclude, without limitation, the following: Ambulatory Surgery Center(ASC) vs hospital, facility trauma level, Comprehensive Care for JointReplacement Program (CJR) or bundle candidacy, a MSA driven score,community vs metro, academic vs non-academic, postoperative networkaccess (Skilled Nursing Facility [SNF] only, Home Health, etc.),availability of medical professionals, implant availability, andavailability of surgical equipment.

These facility inputs can be captured by, for example and withoutlimitation, Surveys (Paper/Digital), Surgery Scheduling Tools (e.g.,apps, Websites, Electronic Medical Records [EMRs], etc.), Databases ofHospital Information (on the Internet), etc. Input data relating to theassociated healthcare economy including, but not limited to, thesocioeconomic profile of the patient, the expected level ofreimbursement the patient will receive, and if the treatment is patientspecific may also be captured.

These healthcare economic inputs can be captured by, for example andwithout limitation, Surveys (Paper/Digital), Direct Payer Information,Databases of Socioeconomic status (on the Internet with zip code), etc.Finally, data derived from simulation of the procedure is captured.Simulation inputs include implant size, position, and orientation.Simulation can be conducted with custom or commercially availableanatomical modeling software programs (e.g., LIFEMOD®, AnyBody, orOpenSIM). It is noted that the data inputs described above may not beavailable for every patient, and the treatment plan will be generatedusing the data that is available.

Prior to surgery, the Patient Data 610, 615 and Healthcare ProfessionalData 625 may be captured and stored in a cloud-based or online database(e.g., the Surgical Data Server 180 shown in FIG. 5C). Informationrelevant to the procedure is supplied to a computing system via wirelessdata transfer or manually with the use of portable media storage. Thecomputing system is configured to generate a case plan for use with aCASS 100. Case plan generation will be described hereinafter. It isnoted that the system has access to historical data from previouspatients undergoing treatment, including implant size, placement, andorientation as generated by a computer-assisted, patient-specific kneeinstrument (PSKI) selection system, or automatically by the CASS 100itself. To achieve this, case log data is uploaded to the historicaldatabase by a surgical sales rep or case engineer using an onlineportal. In some embodiments, data transfer to the online database iswireless and automated.

Historical data sets from the online database are used as inputs to amachine learning model such as, for example, a recurrent neural network(RNN) or other form of artificial neural network. As is generallyunderstood in the art, an artificial neural network functions similar toa biologic neural network and is comprised of a series of nodes andconnections. The machine learning model is trained to predict one ormore values based on the input data. For the sections that follow, it isassumed that the machine learning model is trained to generate predictorequations. These predictor equations may be optimized to determine theoptimal size, position, and orientation of the implants to achieve thebest outcome or satisfaction level.

Once the procedure is complete, all patient data and available outcomedata, including the implant size, position and orientation determined bythe CASS 100, are collected and stored in the historical database. Anysubsequent calculation of the target equation via the RNN will includethe data from the previous patient in this manner, allowing forcontinuous improvement of the system.

In addition to, or as an alternative to determining implant positioning,in some embodiments, the predictor equation and associated optimizationcan be used to generate the resection planes for use with a PSKI system.When used with a PSKI system, the predictor equation computation andoptimization are completed prior to surgery. Patient anatomy isestimated using medical image data (x-ray, CT, MRI). Global optimizationof the predictor equation can provide an ideal size and position of theimplant components. Boolean intersection of the implant components andpatient anatomy is defined as the resection volume. PSKI can be producedto remove the optimized resection envelope. In this embodiment, thesurgeon cannot alter the surgical plan intraoperatively.

The surgeon may choose to alter the surgical case plan at any time priorto or during the procedure. If the surgeon elects to deviate from thesurgical case plan, the altered size, position, and/or orientation ofthe component(s) is locked, and the global optimization is refreshedbased on the new size, position, and/or orientation of the component(s)(using the techniques previously described) to find the new idealposition of the other component(s) and the corresponding resectionsneeded to be performed to achieve the newly optimized size, positionand/or orientation of the component(s). For example, if the surgeondetermines that the size, position and/or orientation of the femoralimplant in a TKA needs to be updated or modified intraoperatively, thefemoral implant position is locked relative to the anatomy, and the newoptimal position of the tibia will be calculated (via globaloptimization) considering the surgeon's changes to the femoral implantsize, position and/or orientation. Furthermore, if the surgical systemused to implement the case plan is robotically assisted (e.g., as withNAVIO® or the MAKO Rio), bone removal and bone morphology during thesurgery can be monitored in real time. If the resections made during theprocedure deviate from the surgical plan, the subsequent placement ofadditional components may be optimized by the processor taking intoaccount the actual resections that have already been made.

FIG. 7A illustrates how the Operative Patient Care System 620 may beadapted for performing case plan matching services. In this example,data is captured relating to the current patient 610 and is compared toall or portions of a historical database of patient data and associatedoutcomes 615. For example, the surgeon may elect to compare the plan forthe current patient against a subset of the historical database. Data inthe historical database can be filtered to include, for example, onlydata sets with favorable outcomes, data sets corresponding to historicalsurgeries of patients with profiles that are the same or similar to thecurrent patient profile, data sets corresponding to a particularsurgeon, data sets corresponding to a particular aspect of the surgicalplan (e.g., only surgeries where a particular ligament is retained), orany other criteria selected by the surgeon or medical professional. If,for example, the current patient data matches or is correlated with thatof a previous patient who experienced a good outcome, the case plan fromthe previous patient can be accessed and adapted or adopted for use withthe current patient. The predictor equation may be used in conjunctionwith an intra-operative algorithm that identifies or determines theactions associated with the case plan. Based on the relevant and/orpreselected information from the historical database, theintra-operative algorithm determines a series of recommended actions forthe surgeon to perform. Each execution of the algorithm produces thenext action in the case plan. If the surgeon performs the action, theresults are evaluated. The results of the surgeon's performing theaction are used to refine and update inputs to the intra-operativealgorithm for generating the next step in the case plan. Once the caseplan has been fully executed all data associated with the case plan,including any deviations performed from the recommended actions by thesurgeon, are stored in the database of historical data. In someembodiments, the system utilizes preoperative, intraoperative, orpostoperative modules in a piecewise fashion, as opposed to the entirecontinuum of care. In other words, caregivers can prescribe anypermutation or combination of treatment modules including the use of asingle module. These concepts are illustrated in FIG. 7B and can beapplied to any type of surgery utilizing the CASS 100.

Surgery Process Display

As noted above with respect to FIGS. 1 and 5A-5C, the various componentsof the CASS 100 generate detailed data records during surgery. The CASS100 can track and record various actions and activities of the surgeonduring each step of the surgery and compare actual activity to thepre-operative or intraoperative surgical plan. In some embodiments, asoftware tool may be employed to process this data into a format wherethe surgery can be effectively “played-back.” For example, in oneembodiment, one or more GUIs may be used that depict all of theinformation presented on the Display 125 during surgery. This can besupplemented with graphs and images that depict the data collected bydifferent tools. For example, a GUI that provides a visual depiction ofthe knee during tissue resection may provide the measured torque anddisplacement of the resection equipment adjacent to the visual depictionto better provide an understanding of any deviations that occurred fromthe planned resection area. The ability to review a playback of thesurgical plan or toggle between different aspects of the actual surgeryvs. the surgical plan could provide benefits to the surgeon and/orsurgical staff, allowing such persons to identify any deficiencies orchallenging aspects of a surgery so that they can be modified in futuresurgeries. Similarly, in academic settings, the aforementioned GUIs canbe used as a teaching tool for training future surgeons and/or surgicalstaff. Additionally, because the data set effectively records manyaspects of the surgeon's activity, it may also be used for other reasons(e.g., legal or compliance reasons) as evidence of correct or incorrectperformance of a particular surgical procedure.

Over time, as more and more surgical data is collected, a rich libraryof data may be acquired that describes surgical procedures performed forvarious types of anatomy (knee, shoulder, hip, etc.) by differentsurgeons for different patients. Moreover, aspects such as implant typeand dimension, patient demographics, etc. can further be used to enhancethe overall dataset. Once the dataset has been established, it may beused to train a machine learning model (e.g., RNN) to make predictionsof how surgery will proceed based on the current state of the CASS 100.

Training of the machine learning model can be performed as follows. Theoverall state of the CASS 100 can be sampled over a plurality of timeperiods for the duration of the surgery. The machine learning model canthen be trained to translate a current state at a first time period to afuture state at a different time period. By analyzing the entire stateof the CASS 100 rather than the individual data items, any causaleffects of interactions between different components of the CASS 100 canbe captured. In some embodiments, a plurality of machine learning modelsmay be used rather than a single model. In some embodiments, the machinelearning model may be trained not only with the state of the CASS 100,but also with patient data (e.g., captured from an EMR) and anidentification of members of the surgical staff. This allows the modelto make predictions with even greater specificity. Moreover, it allowssurgeons to selectively make predictions based only on their ownsurgical experiences if desired.

In some embodiments, predictions or recommendations made by theaforementioned machine learning models can be directly integrated intothe surgical workflow. For example, in some embodiments, the SurgicalComputer 150 may execute the machine learning model in the backgroundmaking predictions or recommendations for upcoming actions or surgicalconditions. A plurality of states can thus be predicted or recommendedfor each period. For example, the Surgical Computer 150 may predict orrecommend the state for the next 5 minutes in 30 second increments.Using this information, the surgeon can utilize a “process display” viewof the surgery that allows visualization of the future state. Forexample, FIG. 7C depicts a series of images that may be displayed to thesurgeon depicting the implant placement interface. The surgeon can cyclethrough these images, for example, by entering a particular time intothe display 125 of the CASS 100 or instructing the system to advance orrewind the display in a specific time increment using a tactile, oral,or other instruction. In one embodiment, the process display can bepresented in the upper portion of the surgeon's field of view in the ARHMD. In some embodiments, the process display can be updated inreal-time. For example, as the surgeon moves resection tools around theplanned resection area, the process display can be updated so that thesurgeon can see how his or her actions are affecting the other aspectsof the surgery.

In some embodiments, rather than simply using the current state of theCASS 100 as an input to the machine learning model, the inputs to themodel may include a planned future state. For example, the surgeon mayindicate that he or she is planning to make a particular bone resectionof the knee joint. This indication may be entered manually into theSurgical Computer 150 or the surgeon may verbally provide theindication. The Surgical Computer 150 can then produce a film stripshowing the predicted effect of the cut on the surgery. Such a filmstrip can depict over specific time increments how the surgery will beaffected, including, for example, changes in the patient's anatomy,changes to implant position and orientation, and changes regardingsurgical intervention and instrumentation, if the contemplated course ofaction were to be performed. A surgeon or medical professional caninvoke or request this type of film strip at any point in the surgery topreview how a contemplated course of action would affect the surgicalplan if the contemplated action were to be carried out.

It should be further noted that, with a sufficiently trained machinelearning model and robotic CASS, various aspects of the surgery can beautomated such that the surgeon only needs to be minimally involved, forexample, by only providing approval for various steps of the surgery.For example, robotic control using arms or other means can be graduallyintegrated into the surgical workflow over time with the surgeon slowlybecoming less and less involved with manual interaction versus robotoperation. The machine learning model in this case can learn whatrobotic commands are required to achieve certain states of theCASS-implemented plan. Eventually, the machine learning model may beused to produce a film strip or similar view or display that predictsand can preview the entire surgery from an initial state. For example,an initial state may be defined that includes the patient information,the surgical plan, implant characteristics, and surgeon preferences.Based on this information, the surgeon could preview an entire surgeryto confirm that the CASS-recommended plan meets the surgeon'sexpectations and/or requirements. Moreover, because the output of themachine learning model is the state of the CASS 100 itself, commands canbe derived to control the components of the CASS to achieve eachpredicted state. In the extreme case, the entire surgery could thus beautomated based on just the initial state information.

Using the Point Probe to Acquire High-Resolution of Key Areas During HipSurgeries

Use of the point probe is described in U.S. patent application Ser. No.14/955,742 entitled “Systems and Methods for Planning and PerformingImage Free Implant Revision Surgery,” the entirety of which isincorporated herein by reference. Briefly, an optically tracked pointprobe may be used to map the actual surface of the target bone thatneeds a new implant. Mapping is performed after removal of the defectiveor worn-out implant, as well as after removal of any diseased orotherwise unwanted bone. A plurality of points is collected on the bonesurfaces by brushing or scraping the entirety of the remaining bone withthe tip of the point probe. This is referred to as tracing or “painting”the bone. The collected points are used to create a three-dimensionalmodel or surface map of the bone surfaces in the computerized planningsystem. The created 3D model of the remaining bone is then used as thebasis for planning the procedure and necessary implant sizes. Analternative technique that uses X-rays to determine a 3D model isdescribed in U.S. Provisional Patent Application No. 62/658,988, filedApr. 17, 2018 and entitled “Three Dimensional Guide with Selective BoneMatching,” the entirety of which is incorporated herein by reference.

For hip applications, the point probe painting can be used to acquirehigh resolution data in key areas such as the acetabular rim andacetabular fossa. This can allow a surgeon to obtain a detailed viewbefore beginning to ream. For example, in one embodiment, the pointprobe may be used to identify the floor (fossa) of the acetabulum. As iswell understood in the art, in hip surgeries, it is important to ensurethat the floor of the acetabulum is not compromised during reaming so asto avoid destruction of the medial wall. If the medial wall wereinadvertently destroyed, the surgery would require the additional stepof bone grafting. With this in mind, the information from the pointprobe can be used to provide operating guidelines to the acetabularreamer during surgical procedures. For example, the acetabular reamermay be configured to provide haptic feedback to the surgeon when he orshe reaches the floor or otherwise deviates from the surgical plan.Alternatively, the CASS 100 may automatically stop the reamer when thefloor is reached or when the reamer is within a threshold distance.

As an additional safeguard, the thickness of the area between theacetabulum and the medial wall could be estimated. For example, once theacetabular rim and acetabular fossa has been painted and registered tothe pre-operative 3D model, the thickness can readily be estimated bycomparing the location of the surface of the acetabulum to the locationof the medial wall. Using this knowledge, the CASS 100 may providealerts or other responses in the event that any surgical activity ispredicted to protrude through the acetabular wall while reaming.

The point probe may also be used to collect high resolution data ofcommon reference points used in orienting the 3D model to the patient.For example, for pelvic plane landmarks like the ASIS and the pubicsymphysis, the surgeon may use the point probe to paint the bone torepresent a true pelvic plane. Given a more complete view of theselandmarks, the registration software has more information to orient the3D model.

The point probe may also be used to collect high-resolution datadescribing the proximal femoral reference point that could be used toincrease the accuracy of implant placement. For example, therelationship between the tip of the Greater Trochanter (GT) and thecenter of the femoral head is commonly used as reference point to alignthe femoral component during hip arthroplasty. The alignment is highlydependent on proper location of the GT; thus, in some embodiments, thepoint probe is used to paint the GT to provide a high resolution view ofthe area. Similarly, in some embodiments, it may be useful to have ahigh-resolution view of the Lesser Trochanter (LT). For example, duringhip arthroplasty, the Don Classification helps to select a stem thatwill maximize the ability of achieving a press-fit during surgery toprevent micromotion of femoral components post-surgery and ensureoptimal bony ingrowth. As is generated understood in the art, the DorrClassification measures the ratio between the canal width at the LT andthe canal width 10 cm below the LT. The accuracy of the classificationis highly dependent on the correct location of the relevant anatomy.Thus, it may be advantageous to paint the LT to provide ahigh-resolution view of the area.

In some embodiments, the point probe is used to paint the femoral neckto provide high-resolution data that allows the surgeon to betterunderstand where to make the neck cut. The navigation system can thenguide the surgeon as they perform the neck cut. For example, asunderstood in the art, the femoral neck angle is measured by placing oneline down the center of the femoral shaft and a second line down thecenter of the femoral neck. Thus, a high-resolution view of the femoralneck (and possibly the femoral shaft as well) would provide a moreaccurate calculation of the femoral neck angle.

High-resolution femoral head neck data could also be used for anavigated resurfacing procedure where the software/hardware aids thesurgeon in preparing the proximal femur and placing the femoralcomponent. As is generally understood in the art, during hipresurfacing, the femoral head and neck are not removed; rather, the headis trimmed and capped with a smooth metal covering. In this case, itwould be advantageous for the surgeon to paint the femoral head and capso that an accurate assessment of their respective geometries can beunderstood and used to guide trimming and placement of the femoralcomponent.

Registration of Pre-Operative Data to Patient Anatomy Using the PointProbe

As noted above, in some embodiments, a 3D model is developed during thepre-operative stage based on 2D or 3D images of the anatomical area ofinterest. In such embodiments, registration between the 3D model and thesurgical site is performed prior to the surgical procedure. Theregistered 3D model may be used to track and measure the patient'sanatomy and surgical tools intraoperatively.

During the surgical procedure, landmarks are acquired to facilitateregistration of this pre-operative 3D model to the patient's anatomy.For knee procedures, these points could comprise the femoral headcenter, distal femoral axis point, medial and lateral epicondyles,medial and lateral malleolus, proximal tibial mechanical axis point, andtibial A/P direction. For hip procedures these points could comprise theanterior superior iliac spine (ASIS), the pubic symphysis, points alongthe acetabular rim and within the hemisphere, the greater trochanter(GT), and the lesser trochanter (LT).

In a revision surgery, the surgeon may paint certain areas that containanatomical defects to allow for better visualization and navigation ofimplant insertion. These defects can be identified based on analysis ofthe pre-operative images. For example, in one embodiment, eachpre-operative image is compared to a library of images showing “healthy”anatomy (i.e., without defects). Any significant deviations between thepatient's images and the healthy images can be flagged as a potentialdefect. Then, during surgery, the surgeon can be warned of the possibledefect via a visual alert on the display 125 of the CASS 100. Thesurgeon can then paint the area to provide further detail regarding thepotential defect to the Surgical Computer 150.

In some embodiments, the surgeon may use a non-contact method forregistration of bony anatomy intra-incision. For example, in oneembodiment, laser scanning is employed for registration. A laser stripeis projected over the anatomical area of interest and the heightvariations of the area are detected as changes in the line. Othernon-contact optical methods, such as white light inferometry orultrasound, may alternatively be used for surface height measurement orto register the anatomy. For example, ultrasound technology may bebeneficial where there is soft tissue between the registration point andthe bone being registered (e.g., ASIS, pubic symphysis in hipsurgeries), thereby providing for a more accurate definition of anatomicplanes.

Osteochondral Implants

In some embodiments, an osteochondral implant can be custom,semi-custom, or custom-selected from several available sizes and shapes.FIG. 8 is a flow diagram of an illustrative method for treatment of anosteochondral defect of a joint. Exemplary method 500 facilitatescreation of a 3D model of an ideal osteochondral surface and allows animplantation plan to be created. This plan can include selection of anavailable implant or creation of a custom implant before surgerydepending on the level of customization in the embodiment. Method 500includes operations such as select/calibrate tools 505, attach trackingarrays 510, collect surface point data 515, generate 3D healthy bonemodel 520, define defect boundary 525, generate 3D implant model 530,manufacture implant 535, generate implantation plan 540, resect jointaccording to implantation plan 545, place implant in resected cavity onjoint 550, and confirm congruency of implant 555. The method 500 can beperformed with more or fewer operations in certain examples. In anembodiment, one or more operations can be performed concurrently. In anembodiment, one or more operations can be performed intraoperatively. Inan embodiment, one or more operations may be performed preoperatively.

As illustrated in step 505, the one or more tools used to collectsurface point data may be calibrated. In an embodiment, the one or moretools may include an instrumented probe. In an embodiment, the one ormore tools may include a handpiece of a robotic surgical system. In anembodiment, the one or more tools may include a location trackingsystem. In an embodiment, the one or more tools may be releasablyattached to a robotic arm.

As illustrated in step 510, tracking arrays may be attached to a portionof the anatomy of a patient on which the defect is located. In anembodiment, the tracking arrays are optical tracking arrays. In anembodiment, the patient's anatomy may be a knee. In an embodiment, thetracking arrays may be attached to one or more of the patient's femurand tibia. In an alternative embodiment, the patient's anatomy may be anankle, a hip, a shoulder, a spine, a wrist, or an elbow.

As illustrated in step 515, an instrumented probe is used to collectsurface point data to map the articular surface of the joint on whichthe defect is located. In an embodiment, the instrumented probe may maponly the portion of the articular surface of the joint having healthybone tissue. In an embodiment, the instrumented probe may map thearticular surface of the joint using Cartesian coordinates, sphericalcoordinates, cylindrical coordinates, or any other suitable coordinatesystem. In an embodiment, mapping the articular surface of the joint isperformed intraoperatively. In an embodiment, mapping the articularsurface of the joint is performed preoperatively.

In some embodiments, the instrumented probe has a blunt tip so as toreduce the risk of piercing healthy cartilage. The blunt tip may have aradius from about 3 mm to about 10 mm. In an additional embodiment, theblunt tip may have a radius from about 4 mm to about 6 mm. In oneembodiment, the blunt tip has a radius of about 4 mm.

As illustrated in step 520, a 3D healthy bone model is generated usingthe mapped articular surface of the joint from step 515. As shown in theflow diagram of FIG. 9, in an embodiment, the articular surface pointdata and data from a database of healthy bone anatomies are applied to astatistical modeling equation to generate a 3D healthy bone model withno bone lesions. In an embodiment, the 3D healthy bone model isgenerated intraoperatively. In an embodiment, the 3D healthy bone modelis generated preoperatively. This bone model may include an idealosteochondral surface to target with an implant to correct the defect.

As illustrated in step 525, the instrumented probe is used to define theboundary of the defect onto the 3D healthy bone model generated in step520. In an embodiment, the instrumented probe is used to define theboundary of the defect before the 3D healthy bone model is generated. Inan embodiment, the instrumented probe may define the boundary of the OCDusing Cartesian coordinates, spherical coordinates, cylindricalcoordinates, or any other suitable coordinate system. In an embodiment,the OCD boundary is defined 525 intraoperatively. In an embodiment, theOCD boundary is defined 525 preoperatively. In an alternativeembodiment, the boundary of the OCD defect may be defined 525 beforegeneration of the 3D healthy bone model 520. In an alternativeembodiment, the boundary of the OCD defect may be defined 525concurrently with or before collecting articular surface point data ofthe joint 515.

As illustrated in step 530, a 3D model of an implant for treating anosteochondral defect of a joint is generated. In an embodiment, thecross-sectional shape of the implant is based on the defect boundarydefined in step 525. In an embodiment, the shape of the articularsurface of the implant is based on the portion of the mapped articularsurface of the joint that is within the boundary of the OCD asdetermined in step 525. In an embodiment, the shape of the articularsurface of the implant is based on the portion of the 3D healthy bonemodel that is within the boundary of the OCD as determined in step 525.In an embodiment, the articular surface may be flat. In an embodiment,the articular surface may be shaped to be one or more of convex,concave, and saddle-shaped. In an embodiment, the preoperative imagesmay be obtained using at least one of an X-ray, computerized tomography,and magnetic resonance imaging. In an embodiment, the dimensions anddesired properties of the implant can be determined based on one or moreof (1) the shape of the articular surface of the implant describedfurther herein, (2) the thickness of the articular cartilage surroundingthe OCD determined based on preoperative images of the joint, and (3)the depth of the OCD determined based on preoperative images of thejoint. In an embodiment, a surgeon could determine the thickness of theimplant intraoperatively. In such an embodiment, the surgeon maydetermine the thickness prior to generating the 3D implant model. In anembodiment, the instrumented probe may be used to determine thethickness of the cartilage at a non-articular portion of the knee usinga Shore hardness test. In an alternate embodiment, the instrumentedprobe may be used to determine the thickness of the cartilage bydetecting the location of the instrumented probe while touching thesurface of the cartilage and then detecting the location of the probewhile touching bone.

In an embodiment, the 3D implant model is generated intraoperatively. Inan embodiment, the 3D implant model is generated preoperatively. Forexample, the portion of the patient's anatomy related to the orthopedicprocedure and the implant is characterized and detailed. Thecharacterization can be performed with various imaging methods capableof obtaining a representation of the affected anatomy, including, forexample, soft and hard tissues. The tissues can include bone, bonejoints with or without cartilage, ligaments, or other soft tissue. Theimaging methods can include, for example, MRI, CT, ultrasound,radiography, X-ray, cameras and other devices. Newer methods can also beused, including, for example, T-ray computed tomography and T-raydiffraction tomography. T-ray is a pulsed terahertz (THz) radiation thatcan be used to image three-dimensional (3D) structures in thefar-infrared region. A T-ray computed tomography system providessectional images of objects similar to conventional CT techniques suchas x-ray, but without the harmful effects of ionizing radiation. See,e.g., Ferguson et al., T-ray Computed Tomography, Opt Lett. Aug. 1,2002; 27(15):1312-4.

Imaging information for the patient can be obtained at a medicalfacility or a doctor's office and can be sent to the manufacturer in anelectronic and/or digital form. The imaging information can be stored ona physical medium, such as a CD, DVD, flash memory device (e.g., memorystick, compact flash, secure digital card), or other storage device. Theinformation may alternatively or additionally be transmittedelectronically via the Internet using an appropriate transfer protocol.Electronic transmissions may further include e-mail or other digitaltransmission to any appropriate type of computer device, smart phone,PDA or other devices to which electronic information can be transmitted.

The imaging information can be used to create a three-dimensional modelor image of the bone or joint with or without associated soft tissue orrelated anatomy using commercially available computer modeling softwarefrom various vendors or developers, such as, for example, MaterialiseUSA of Ann Arbor, Mich. The three-dimensional model of the patient'sanatomy can be viewed on a computer display or other electronic screenand can also be reproduced as a hard copy on film or other medium andviewed by direct, indirect, or backlight illumination. The model can besized for viewing on any appropriate screen size and may be cropped,rotated, etc. as selected by an individual (e.g., the surgeon) viewingthe screen.

Soft tissue associated with the affected anatomy can be modified,removed, or repaired to restore alignment of the joint, to remove tornor diseased tissue, to cut or repair ligaments, or to provide natural orartificial ligament grafts. Soft tissue information can optionally beused as an additional design parameter or input for the implant design.Further, kinematic information for the patient can be obtained by gaitanalysis of the patient or by computer modeling software. The computermodeling software may use MRI images of the patient's joints andassociated ligaments, muscle or other soft tissue to perform a kinematicanalysis of the patient and make corresponding recommendations for softtissue modification, such as releasing a ligament. Such software iscommercially available from the Biomechanics Research Group, Inc., ofSan Clemente, Calif.

A preliminary pre-operative plan of the surgical procedure can beprepared for surgeon or other medical user or technician review,including planning bone resections, sizes and shapes of implants, andvarious geometric requirements including relevant dimensions, such asheight, width, orientation of particular features, and the like. Thepreliminary pre-operative surgical plan can include a recommendation ofparticular implants and associated instruments to be used in thesurgical procedure as discussed below. The preliminary pre-operativesurgical plan may include digital images that can be viewedinteractively using a computer modeling software, such as the softwarereferenced above. The preliminary pre-operative plan and any furtherchanges or a finalized pre-operative plan can be a plan devised toobtain a healthy or as close to healthy anatomical orientation after anoperative procedure. The healthy anatomy can be based on natural orpre-injury anatomy or mechanically correct or efficient anatomicalorientation.

The preliminary pre-operative surgical plan can be submitted to thesurgeon (or other user) for review, either electronically or by landmail, and either in digital or hard copy form, as discussed above inconnection with transmitting imaging information. In particular, thesurgeon can review the bone resection shown in an image of the patient'sanatomy, make changes in the location, size, shape and/or orientation ofthe implant and, generally, work interactively until the pre-operativeplan is surgeon-approved. Following the surgeon's approval of theanatomy and the implant, the surgeon is provided with the opportunity toremove one or more osteophytes/protrusions from the image of thepatient's anatomy at surgeon-selected locations and depths. Removal ofsuch protrusions and smoothening of the joint surface that receives theimplant can parallel the intra-operative joint preparation by thesurgeon and improve the actual fit of a surgeon-selected implant,whether patient-specific, semi-custom, or off-the-shelf.

As illustrated in step 535, an implant may be manufactured based on the3D implant model generated in step 530. In some embodiments, the implantis selected from a plurality of available implant models having avariety of dimensions, shapes, or chondral surface intrinsiccharacteristics. In an embodiment, the implant may be manufactured usingone or more additive techniques. Additive techniques may include, forexample, bio-plotting, fused deposition modeling (FDM), selective lasersintering (SLS), and stereolithography (SLA). In an embodiment, themanufacturing system may use one or more machining techniques. Machiningtechniques may include, for example, 5-axis computer numerical control(CNC). In an embodiment, a standard blank implant may be manufacturedusing one or more additive techniques and then refined using one or moremachining techniques based on the 3D implant model generated in step530. In an embodiment, refining a standard implant based on the 3Dimplant model may be performed intraoperatively.

In an embodiment, manufacturing the implant based on the 3D implantmodel includes manufacturing an implant according to the 3D model usingone or more additive techniques. In an embodiment, the implant may beintraoperatively manufactured according to the 3D implant model usingone or more additive techniques. In an embodiment, the implant may bepreoperatively manufactured according to the 3D implant model using oneor more additive techniques. In an alternative embodiment, a standardimplant is manufactured using one or more additive techniques and thenshaped according to the 3D implant model using one or more machiningtechniques. In an embodiment, the standard implant may beintraoperatively manufactured using one or more additive techniques. Inan embodiment, the standard implant may be preoperatively manufacturedusing one or more additive techniques. In an embodiment, the standardimplant may be intraoperatively shaped according to the implant model.In an embodiment, the standard implant may be preoperatively shapedaccording to the 3D implant model.

In an embodiment, manufacturing the implant based on the 3D implantmodel includes separately manufacturing one or more of the firstsegment, the second segment, and the one or more additional segments, asdescribed further herein, and assembling them. In an embodiment,manufacturing the implant based on the 3D implant model includessuccessively manufacturing one or more of the first segment, the secondsegment, and the one or more additional segments, as described furtherherein, using additive techniques. In an embodiment, one or morecoatings may be applied to the implant using one or more additivetechniques.

In an embodiment, manufacturing the implant further includes sterilizingthe manufactured implant for implantation. Sterilizing includes, forexample, steam sterilization, dry heat sterilization, chemicalsterilization, radiation sterilization, or any other suitable method.Steam sterilization includes, for example, flash sterilization. Chemicalsterilization includes, for example, ethylene oxide sterilization.

As illustrated in step 540, an implantation plan may be generated. In anembodiment, generating the implantation plan may include determining thesize, shape, location, and orientation of a cavity on the joint with theOCD for receiving the implant. In an embodiment, generating theimplantation plan may include orienting the 3D implant model relative tothe 3D healthy bone model to determine the proper location andorientation of the cavity on the joint. In an embodiment, generating theimplantation plan may include determining the size and shape of thecavity on the joint for receiving the implant based on the 3D implantmodel.

As illustrated in step 545, the joint may be resected to create a cavityon the joint for receiving the implant according to the implantationplan. In an embodiment, the resection may be performed by a CASS 100 orother surgical system. In some embodiments, resection may be performedwith the assistance of a robotic arm. In an embodiment, the cavity maybe shaped based on the 3D implant model to receive the implant. In anembodiment, resecting the joint to form a cavity on the joint mayinclude removing the OCD. In an embodiment, removing the OCD includespreventing the removal of excess tissue using control instructionsprovided to the robotic surgical system. In an embodiment, preventingthe removal of excess tissue includes controlling at least one of aspeed and depth of a burr of the surgical robot. In an embodiment,preventing the removal of excess tissue includes stopping the motion ofa burr of a surgical robot when the burr reaches a boundary of theplanned cavity.

In some embodiments, resection 545 is performed by a surgeon with theassistance of a CASS 100 or robotically assistive surgical system, suchas the NAVIO system. For example, fiducial markers on the surgeon's toolcan be observed via a robotic vision system, and the operation of thetool can be governed by a processor in accordance with the surgicalplan, thereby preventing the resection cavity from being too large ordeviating from the surgical plan. This ensures proper fit of theimplant.

In an embodiment, the operations of manufacturing 535 the implant andone or more of generating 540 an implantation plan and resecting 545 thejoint according to the implantation plan may be performed concurrently.The shape of the resection of patient material and cartilage isdetermined from the implantation plan. The three-dimensional cavitycreated by this resection should match corresponding surfaces of theimplant. Depending on the tools used, the shape can be a rounded recessor a square recess.

As illustrated in step 550, the implant may be placed into the resectedcavity on the joint. In an embodiment, the implant may be press-fittedinto the cavity. In an embodiment, an adhesive may be applied to theimplant before the implant is placed into the cavity. In an embodiment,the adhesive may be a biocompatible adhesive. In an embodiment, theadhesive may be a collagen adhesive. In some embodiments, the implantcan include a bone tissue interfacing surface that is designed toencourage interlocking bone tissue growth into the implant. For example,a bio-inert material, such as titanium or tantalum, can be manufacturedinto a porous matrix or have a coating to provide a substrate onto whichbone adheres as it heals. One exemplary material for this bone tissueinterfacing surface is CONCELOC porous titanium from Smith and Nephew.CONCELOC is a registered trademark of SMITH & NEPHEW, INC. of Memphis,Tenn. Other exemplary interfacing surface materials include tantalum ortitanium alloys having a porous matrix or coating, such as those thattrade under the marks TRABECULAR METAL, REGENEREX, TRITANIUM, STIKTITE,or GRIPTION. TRABECULAR METAL and REGENEREX are registered trademarks ofZimmer Biomet of Warsaw, Ind. TRITANIUM is a registered trademark ofStryker Corp. of Kalamazoo, Mich. STIKTITE is a registered trademark ofSMITH & NEPHEW, INC. of Memphis, Tenn. GRIPTION is a registeredtrademark of DePuy Synthes of Warsaw, Ind. In some embodiments,inserting and securing the implant may include inserting one or morescrews or pins to help secure the implant while bone grows into theimplant.

In an embodiment, the implant may further include the injection of oneor more materials around an outer surface of the implant or into abone-mating surface of the implant to aid in adherence or bonding toresected bone and in regeneration of tissue to mechanically interlockthe implant as the bone heals. In an embodiment, the material may be afluid. In an embodiment, the type of cartilage may be a synthetichyaline-like cartilage. In an embodiment, the fluid may includechondrocytes, moselized bone, blood platelet concentrate, bone marrow,stem cells, growth factors, extracellular matrix (ECM), or a combinationthereof. In an embodiment, the fluid may stimulate growth of a type ofbone. In an embodiment, the type of bone may be subchondral bone. In anembodiment, the type of bone may be cancellous bone. Stem cells mayinclude progenitor cells, for example, embryonic stem cells, mesenchymalstem cells (MSCs) and adipose tissue-derived stem cells. Growth factorsmay include, for example, vascular endothelial growth factors (VEGF),insulin-like growth factors (IGF), transforming growth factors (TGF),fibroblast derived growth factors (FDGF), platelet derived growthfactors (PDGF), and bone morphogenic protein (BMP). In an embodiment,the injection may be performed one or more of intraoperatively andpostoperatively. In an alternative embodiment, the injection may beperformed preoperatively.

In an embodiment, placing the implant into the resected cavity 550 mayfurther include inserting a surgical instrument through one or morechannels formed in the implant, such as the channels described furtherherein, to the bone of the cavity on the joint. In an embodiment, thesurgical instrument may be used to stimulate blood flow from the bonesurrounding the cavity on the joint. In an embodiment, the bonesurrounding the cavity on the joint may be subchondral bone. In anembodiment, the bone surrounding the cavity on the joint may becancellous bone. In an embodiment, the surgical instrument may be one ormore of a surgical drill and a surgical pick.

In some embodiments, a CASS may be used to place a pin in the bone atthe OCD site. In some embodiments, a cannula may be placed over the pin.The cannula may be used to remove bone from the OCD site. In someembodiments, a physical stop may be used to limit the cavity depth.Alternatively, the CASS may be used to control the cavity depth. In someembodiments, a plurality of pins may be placed at the OCD site. Theplurality of pins may be used to create a shape, such as an oval shape,an ovoid shape, or a triangular shape.

As illustrated in step 555, the congruency of the implant with thesurrounding tissue of the joint may be confirmed. In an embodiment, thesurrounding tissue of the joint may comprise the surrounding articulartissue. In an embodiment, the instrumented probe may be used to map thepost-implantation articular surface of the joint to create apost-implantation surface map. In an embodiment, the post-implantationsurface map may be compared with the database of healthy bone anatomiesusing one or more comparison techniques to assess the congruency of theimplant with the surrounding articular tissue. Comparison techniques mayinclude, for example and without limitation, overlapping metrics andvolume and surface metrics. Overlapping metrics may include, forexample, using the Dice similarity coefficient. Volume and surfacemetrics may include, for example, assessing the maximum and meandistance errors.

In some embodiments, confirming 555 the congruency of the implant withthe surrounding tissue may include shaving or planing the surface of theimplant so that the surface is flush with the existing osteochondralmaterial. Shaving or planing the surface may ensure that the matingsurface of the implant and the matching cartilage surface on other bonesin the joint interact without causing additional strain on the implant.As such, the artificial cartilage of the implant may smoothly interfacewith the corresponding matching surface of other bones of the joint whenmoved through a range of motion.

In an alternate embodiment, the 3D implant model may be compared toexisting implant models stored in a database to select an existingimplant that most closely matches the generated 3D implant model.Information pertaining to the existing implant model may be used togenerate 540 the implantation plan. In some embodiments, the existingimplant model may be machined or over-molded 535 to conform the existingimplant to the 3D implant model.

FIG. 10 is a block diagram of an illustrative system for treatment of anosteochondral defect of a joint. As shown in FIG. 10, the system 700includes components such as a tool for capturing joint data 705, asurgical system 710, a processor 715, and a manufacturing/selectionsystem 720. The system 700 can include more or fewer components incertain examples. In an embodiment, the surgical system 710 may be aCASS or a robotic surgical system. In an embodiment, the tool forcapturing joint data 705 may be in electronic communication with one ormore of the surgical system 710, the processor 715, and themanufacturing/selection system 720. In an embodiment, the surgicalsystem 710 may be in electronic communication with one or more of theprocessor 715 and the manufacturing/selection system 720. In anembodiment, the processor 715 may be in electronic communication withthe manufacturing/selection system 720. In an embodiment, electroniccommunication may occur via a wired transmission system. In an alternateembodiment, electronic communication may occur via a wirelesstransmission system. In such an embodiment, the wireless transmissionsystem may receive information from one or more of the tool forcapturing joint data 705, the surgical system 710, the processor 715,and the manufacturing/selection system 720 and convert the informationinto digital information that may be wirelessly transmitted to one ormore of the tool for capturing joint data 705, the surgical system 710,the processor 715, and the manufacturing/selection system 720.

In an embodiment, the tool for capturing joint data 705 may be aninstrumented probe. In an embodiment, the tool for capturing joint data705 may be configured to capture surface point data to map the articularsurface of a joint on which the OCD is located. In an embodiment, thetool for capturing joint data 705 may be configured to define a boundaryof an OCD on the joint. In an embodiment, the tool for capturing jointdata 705 may be configured to capture surface point data to map thearticular surface of the joint after an implant for treatment of the OCDhas been implanted. In an embodiment, the tool for capturing joint data705 may be used intraoperatively. In an embodiment, the tool forcapturing joint data 705 may be used preoperatively.

In an embodiment, the surgical system 710 may be configured to form acavity on a joint based on an implantation plan, such as is describedfurther herein. In an embodiment, the surgical system 710 may beconfigured to repair an OCD by forming a cavity on the joint. In anembodiment, the surgical system 710 may be a robotic surgical system,such as a CASS. In an embodiment, the surgical system 710 may beconfigured to prevent the removal of excess tissue from the joint usingcontrol instructions provided to the robotic surgical system. In anembodiment, preventing the removal of excess tissue may includecontrolling at least one of a speed and a depth of a burr of thesurgical robot. In an embodiment, preventing the removal of excesstissue may include stopping the motion of a burr of a surgical robotwhen the burr reaches a boundary of the planned cavity. In anembodiment, preventing the removal of excess tissue may includewithdrawing a burr of a surgical robot into a body of the surgical robotwhen the burr reaches a boundary of the planned cavity.

In an embodiment, the processor 715 may be configured to receive surfacejoint data of a joint. In an embodiment, the processor 715 may beconfigured to receive surface joint data of a joint from the tool forcapturing joint data 705. In an embodiment, the processor 715 may beconfigured to receive data defining a boundary of an OCD on a joint. Inan embodiment, the processor 715 may be configured to receive datadefining a boundary of an OCD on a joint from the tool for capturingjoint data 705. In an embodiment, the processor 715 may be configured toreceive surface point data of an articular surface of the joint after animplant for treatment of the OCD has been implanted in the joint. In anembodiment, the processor 715 may be configured to receive surface pointdata of an articular surface of the joint after an implant for treatmentof the OCD has been implanted in the joint from the tool for capturingjoint data 705. In an embodiment, the processor 715 may be configured toreceive data from a database of healthy bone anatomies. In anembodiment, the processor 715 may be configured to access data from adatabase of healthy bone anatomies. In an embodiment, the processor 715may be configured to generate a 3D healthy bone model based on one ormore of surface joint data of a joint, data defining the boundary of anOCD on the joint, and data from a database of healthy bone anatomies,such as the 3D healthy bone model described further herein. In anembodiment, the processor 715 may be configured to generate a 3D implantmodel based on one or more of the 3D healthy bone model and datadefining the boundary of an OCD on a joint, such as the 3D implant modeldescribed further herein. In an embodiment, the processor 715 may beconfigured to generate an implantation plan based on one or more ofsurface joint data of a joint, data defining the boundary of an OCD onthe joint, and the 3D implant model, such as the one described furtherherein.

In an embodiment, the processor 715 may be configured to assess thecongruency of the implant with the surrounding tissue of the joint. Inan embodiment, the surrounding tissue of the joint may be thesurrounding articular tissue. In an embodiment, the tool for capturingjoint data 705 may be used to map the post-implantation articularsurface of the joint to create a post-implantation surface map. In anembodiment, the post-implantation surface map may be compared with thedatabase of healthy bone anatomies using one or more comparisontechniques to assess the congruency of the implant with the surroundingarticular tissue. Comparison techniques may include, for example,overlapping metrics or volume and surface metrics. Overlapping metricsmay include, for example, using the Dice similarity coefficient. Volumeand surface metrics may include, for example, assessing the maximum andmean distance errors.

In an embodiment, the processor 715 provides the 3D implant model to oneor more of the manufacturing/selection system 720 and the surgicalsystem 710. In an embodiment, the processor 715 provides the 3D implantmodel to the manufacturing/selection system 720 and the surgical system710 concurrently. In an embodiment, the processor 715 may furtherinclude a user interface configured to facilitate user assessment of oneor more of the 3D healthy bone model, the 3D implant model, theimplantation plan, and congruency of the implant with the surroundingtissue of the joint.

In an embodiment, the manufacturing/selection system 720 uses one ormore additive techniques to manufacture custom implants responsive tothe processor 715 and the results obtained by the tool for capturingjoint data 705. In some embodiments, the manufacturing/selection system720 recommends a prefabricated implant that suits the needs of thepatient's particular OCD. The manufacturing techniques can include anytechniques discussed herein. In an embodiment, an additive techniqueallows for the creation of interconnected porosity within a manufactureditem. In an embodiment, the manufacturing/selection system 720 may useone or more machining techniques. Machining techniques may include, forexample, 5-axis computer numerical control (CNC). In some embodiments,the manufacturing/selection system 720 may use one or more additivetechniques, such as bio-plotting, fused deposition modeling (FDM),selective laser sintering (SLS), and stereolithography (SLA).

In some embodiments, a bio-inert material (e.g., titanium, tantalum,stainless steel, or an alloy thereof) may be used with the one or moreadditive techniques to form a rigid or semi-rigid substrate onto whichsimulated cartilage can be over-molded through an injection moldingprocess. This may result in simulated cartilage that has desiredintrinsic properties (e.g., compliance, absorbency, permeability, etc.)and extrinsic properties (e.g., dimensions and shape) and a substratethat can be affixed to the bone via adhesives or interconnection viabone growth. Traditionally, certain synthetic cartilage materials havebeen difficult to manufacture in a manner that provides sufficientadhesion to a metal base layer substrate or to bone. Embodiments addressthis issue by using a metal substrate that includes a porous layer toallow the simulated cartilage material to be injected into andmechanically interlock with the substrate during injection molding. Oncethe simulated cartilage material cures, a strong mechanical adhesionforms between the metal substrate and the molded simulated cartilage.

In some embodiments, the substrate onto which the synthetic cartilage isover-molded includes a layer constructed of CONCELOC or a similarmaterial. CONCELOC is a titanium alloy (Ti-6Al-4V) constructed via laseror electron beam deposition that sinters metal powder on alayer-by-layer manner to create an interconnected network of randompores with a porosity of up to 80% near the surface. Generally, overallporosity is around 65% in some embodiments. Typical pore sizes rangefrom 202 μm to 934 μm, in some embodiments, although other suitableranges can be used to optimize adhesion to synthetic cartilage or bone.This provides a porous matrix into which synthetic cartilage can beinjected during an over-molded injection molding process. In someembodiments, top and bottom layers of the substrate are constructed of aporous titanium alloy, such as CONCELOC, allowing injection molding ofthe synthetic cartilage on top and an exposed porous surface on thebottom that provides a matrix for interlocking with bone as it heals.

FIG. 11 is a cross-sectional diagram of an exemplary synthetic cartilageimplant 800 for repairing an OCD (not necessarily to scale). There aretwo primary components to the implant 800: a substrate 802 and asynthetic cartilage material 804. In some embodiments, the substrate 802is a 3D printed (additive manufacturing) structure comprising a titaniumalloy printed to include a first porous matrix 806, an interveningnonporous section 808 and a second porous matrix 810. In someembodiments, sections 806, 808, and 810 are all adequately manufacturedusing the same sintered material. The size of the pores for the firstand second porous matrices 806 and 810 can be selected based on thematerials for the interface. The first porous matrix 806 may interfacewith cortical or cancellous bone depending on the preoperative plan. Asthe bone heals, the bone structure grows into the interconnected poresof the first porous matrix 806 to create a mechanical interlockingstructure to secure the implant 800 to the healing bone. The secondporous matrix 810 provides a lattice substrate into which the syntheticcartilage polymer material 804 can be injected during an over-moldingprocess. As the polymer material 804 cures, the polymer material istrapped in the interconnecting pores of the second porous matrix 810,which causes the polymer material to be mechanically interlocked to thesubstrate 802. The relative pore size and depth of matrices 806 and 810can differ in accordance with the mechanical needs of the substrate 802.The intervening nonporous section 808 serves to provide a barrierbetween the porous matrices 806 and 810. More particularly, theintervening nonporous section 808 prevents the synthetic cartilagepolymer material 804 from seeping into the first porous matrix 806, andensures that the first porous matrix can be used entirely for bonegrowth. The exact dimensions of the substrate 802 are dictated by thepre-surgical plan and the extent of the OCD injury being repaired.

In an embodiment, the porous matrices 806 and 810 have interconnectedporosity. In an embodiment, the porous matrices 806 and 810 have apolyhedral structure. In an embodiment, the polyhedral structure may bea combination of one or more lattice structures. The lattice structuresmay be, for example, cubic, diamond-shaped, tetrahedral, octahedral, orany other suitable structure. In an embodiment, the porous matrices 806and 810 have a structure to mimic a type of bone. In an embodiment, themimicked bone type may be subchondral bone. In an embodiment, themimicked bone type may be cancellous bone. In an embodiment, the porousmatrices 806 and 810 have pores having a diameter in the range of about30-500 micrometers (μm). For example, the porous matrices 806 and 810have pores having a diameter in the range of about 30-250 μm. In anembodiment, the porous matrices 806 and 810 have pores having a diameterin the range of about 30-150 μm. In an embodiment, the porous matrices806 and 810 have pores having a diameter in the range of about 500-700μm. In some embodiments, the porous matrices 806 and 810 have poreshaving a diameter in the range of about 202-934 μm. In variousembodiments, the material chosen for the substrate 802 comprises one ormore metals. Such metals may include, for example, porous titanium,titanium, titanium alloy, stainless steel, tantalum, or any othersuitable material. In some embodiments, porous matrices 806 and 810 mayhave different porosity and pore sizes optimized to receive bone growthand polymer materials, respectively.

The synthetic cartilage material 804 comprises one or more polymers thatare over-molded via an injection molding process to interlock with poresin the second porous matrix 810 and secure the synthetic cartilagematerial to the substrate 802. In an embodiment, the synthetic cartilagematerial 804 comprises one or more synthetic organic polymers, one ormore natural polymers, a copolymer of one or more thereof, or a blend ofone or more thereof. In some embodiments, synthetic organic polymers mayinclude, for example, porous polyurethane, polyurethane, acrylonitrilebutadiene styrene (ABS), polylactic acid (PLA), polylactic-co-glycolicacid) (PLGA), poly(ε-caprolactone) (PCL), polyether ether ketone (PEEK),poly(ethylene glycol) (PEG), ultra-high molecular weight polyethylene(UHMWPE), polyether urethane or any other suitable material. Naturalpolymers include, for example, chitosan, collagen, gelatin, or any othersuitable material.

In some embodiments, the synthetic cartilage material 804 comprisesfully interpenetrating polymer networks (IPNs) and semi-interpenetratingpolymer networks (semi-IPNs). IPNs and semi-IPNs can combine thebeneficial properties of the polymers from which they are made and canavoid some of the undesirable properties of their component polymers.Exemplary IPNs utilize polymers and may be hydrophobic polymers in someembodiments. The polymers may be thermoset, thermoplastic, linked, orcross-linked. By introducing a solvent, monomer, or another polymer tothese polymers, new properties can be imparted. For example,lubriciousness can be introduced to a thermoplastic material by addingpolymerizing ionic monomers/polymers. An otherwise hydrophobic polymercan be made to be hydrophilic, resulting in a low friction surface thatmimics natural cartilage. By converting otherwise hydrophobic materialsinto biphasic materials with both solid and liquid (hydrated) phases,high strength and lubriciousness can be introduced to a singlethermoplastic. An exemplary synthetic cartilage material 804 includespolyether urethane (PEU) that can be linked to a second polymer aftermolding. For example, acrylic acid, such as polyacrylic acid (PAA), canbe added to cross-link with the PEU to cause the resulting IPN to behydrophilic and swell in an aqueous solution. This allows the portion ofthe polymer that has been crosslinked to become lubricious, to create asurface of the strong or rigid polymer that has low friction when usedas a synthetic cartilage. This allows for the creation of strongsynthetic cartilage that has desirable surface qualities and surfacecompliance. Various suitable polymer materials for creation of theseIPNs and semi-IPNs are discussed in detail in U.S. Pat. No. 8,883,915 toMyung, which is incorporated herein by reference. In an alternativeembodiment, the synthetic cartilage material may be made from apolyglycolic acid (PGA). For example, the synthetic cartilage materialmay be a PGA/PGA gel available from Poly-Med, Inc. of Anderson, S.C.

Polymer material 804 can be any thermoset or thermoplastic polymer thatis suitable for an injection molding process and that can becross-linked to a suitable polymer or monomer to create an IPN orsemi-IPN having properties suitable for mimicking cartilage. In someembodiments, the polymer material 804 is a PEU material. To create apolymer material 804 having the desired shape that is bonded to thesubstrate 802, an over-molding injection molding process is used. Asurface 812 of the polymer material 804 matches that of an injectionmold. This injection mold can be created via a machining technique or anadditive manufacturing process, such as 3-D printing. The exact shape ofthe surface 812 can be created using a standard mold or a mold that iscustomized to the patient anatomy based on a 3-D model of the desiredcartilage shape. In some embodiments, the implant 800 is selected from aplurality of pre-manufactured implant designs, such that an implanthaving a surface 812 that most closely matches the ideal 3-D model isselected. In some embodiments, a custom mold is created for eachpatient, such that the surface 812 precisely approximates the idealsurface for implanting the 3-D model.

The over-molding process begins by setting the substrate 802 into a moldthat includes sidewalls and a surface that matches the surface 812. Thisallows the substrate 802 to be over-molded. The resulting chambercreated by the nonporous section 808, the walls of the mold, and themold surface that matches the surface 812 is evacuated to remove air. Aheated thermoplastic or thermoset polymer (or a polymer that can becured from a liquid state) is injected under pressure into the evacuatedchamber. This causes the liquid polymer to seep into the pores of thesecond porous matrix 810 under pressure. Thus, the interconnecting poresof second porous matrix 810 are generally filled with the liquidpolymer. As the polymer material 804 cools/cures, the polymer creates astrong interconnecting bond with the second porous matrix 810. Oncecooled/cured, the polymer material 804 and the substrate 802 arepermanently fused, thereby creating a pseudo-monolithic structure.

Once the polymer material 804 is over-molded onto the substrate 802, thesurface 812 is exposed to a suitable solvent, polymer, or monomer, suchas PAA, to create an IPN or semi-IPN. The exact process by which thepolymer/monomer and over-molded polymer are cross-linked can be anysuitable process known in the art, such as those processes discussed inU.S. Pat. No. 8,883,915. This results in multiple layers within thepolymer material 804. A surface layer 814, closest to the surface 812,may be thoroughly cross-linked, thereby creating an essentiallyheterogeneous IPN or semi-IPN. A second transition layer 816 maycomprise a gradient of cross-linked polymer between a fully cross-linkedIPN/semi-IPN and the original polymer material. A third layer 820 maycomprise the original thermoplastic or thermoset polymer and have thesame intrinsic qualities as that polymer. For example, the third layer820 can be hydrophobic and rigid. In contrast, the surface layer 814 canbe hydrophilic and compliant once hydrolyzed. The surface layer 814 cantherefore act like a hydrogel with properties similar to cartilage.Meanwhile, the other two layers 816 and 820 may provide rigidity andtransition between the lubricious absorptive surface layer 814 and thesubstrate 802. This creates a synthetic cartilage that is sturdy, butalso compliant and lubricious to closely mimic properties of naturalcartilage. Because the substrate 802 includes a first porous layer 806,this synthetic cartilage implant has a surface layer 814 and a surface812 that mimic natural cartilage, while also fusing to patient bone asit heals.

Once manufactured, the implant 800 can be implanted into a resected bonecavity, and an aqueous solution can be applied to saturate and activatethe surface layer 814 and the second transition layer 816.Alternatively, such layers 814 and 816 can be activated at the time ofmanufacture. Once implanted, the surgeon can maneuver the implant 800such that the edges of the surface 812 are flush with surroundingcartilage. This can be achieved by planing portions of the surface layer814 to remove any inconsistencies after implantation or by pressing ortapping the implant 800 with a tool that spans the gap between theexisting cartilage and the edges of the surface 812.

FIG. 12 is a side view of an exemplary synthetic cartilage implant 900for repairing an OCD (not necessarily to scale). There are two primarycomponents to the implant 900: a substrate 902 and a synthetic cartilagematerial 904. In some embodiments, the substrate 902 is in the style ofa screw-in or push-in bone anchor and includes a first portion 906, anintervening nonporous section 908 and a second portion 910. In someembodiments, sections 906, 908, and 910 are all adequately manufacturedusing the same material. The substrate 902 may be cannulated. The firstportion 906 may interface with cortical or cancellous bone, depending onthe preoperative plan. The first portion 906 may be threaded or havefeatures, such as wings or ribs, that enable locking into bone afterinsertion. The first portion 906 may be shaped and of a material similarto that of a BIORAPTOR bone anchor or a HEALICOIL bone anchor. BIORAPTORand HEALICOIL are registered trademarks of Smith & Nephew, Inc. ofMemphis, Tenn. The second portion 910 provides a lattice substrate intowhich the synthetic cartilage polymer material 904 can be injectedduring an over-molding process. As the polymer material 904 cures, thepolymer material is trapped in the interconnecting pores of the secondportion 910, which causes the polymer material to be mechanicallyinterlocked to the substrate 902. The intervening nonporous section 908prevents the synthetic cartilage polymer material 904 from seeping intothe first portion 906 and ensures that the first portion can be usedentirely for bone growth. The exact dimensions of the substrate 902 aredictated by the pre-surgical plan and the extent of the OCD injury beingrepaired. In some embodiments, the substrate or the synthetic cartilagematerial may include structure (such as tabs, hexagonal sides, or slots)that allows a tool to fit over the implant and impart rotation.

FIGS. 13-15 illustrate examples of synthetic cartilage implant shapes.In FIG. 13, the implant is generally a round cylinder. In FIG. 14, theimplant is generally in the form of two or more overlapping cylinders.In FIG. 15, the implant has arcuate sides and straight ends. Thosehaving ordinary skill in the art would understand that the implant canhave any number of shapes or that the depicted shapes could be combined.

While the implants and methods discussed herein have generally alludedto a small implantable plug that only replaces a small OCD, it should beappreciated that these methods and implants could also be used forlarger defects, such as partial or total knee or hip arthroplasty.

For purposes of this application, an “interpenetrating polymer network”or “IPN” is a material comprising two or more polymer networks which areat least partially interlaced on a molecular scale, but not covalentlybonded to each other, and cannot be separated unless chemical bonds arebroken. A “semi-interpenetrating polymer network” or “semi-IPN” is amaterial comprising one or more polymer networks and one or more linearor branched polymers characterized by the penetration on a molecularscale of at least one of the networks by at least some of the linear orbranched macromolecules. As distinguished from an IPN, a semi-IPN is apolymer blend in which at least one of the component polymer networks isnot chemically crosslinked by covalent bonds.

A “polymer” is a substance comprising macromolecules, includinghomopolymers (a polymer derived one species of monomer) and copolymers(a polymer derived from more than one species of monomer). A“hydrophobic polymer” is a pre-formed polymer network having at leastone of the following two properties: (1) a surface water contact angleof at least 45° and (2) exhibits water absorption of 2.5% or less after24 hours at room temperature according to ASTM test standard D570. A“hydrophilic polymer” is a polymer network having a surface watercontact angle less than 45° and exhibits water absorption of more than2.5% after 24 hours at room temperature according to ASTM test standardD570. An “ionic polymer” is defined as a polymer comprised ofmacromolecules containing at least 2% by weight ionic or ionizablemonomers (or both), irrespective of their nature and location. An“ionizable monomer” is a small molecule that can be chemically bonded toother monomers to form a polymer and which also has the ability tobecome negatively charged due the presence of acid functional groupssuch carboxylic acid and/or sulfonic acid. A “thermoset polymer” is onethat doesn't melt when heated, unlike a thermoplastic polymer. Thermosetpolymers “set” into a given shape when first made and afterwards do notflow or melt, but rather decompose upon heating and are often highlycrosslinked and/or covalently crosslinked. A “thermoplastic polymer” isone which melts or flows when heated, unlike thermoset polymers.Thermoplastic polymers are usually not covalently crosslinked. “Phaseseparation” is defined as the conversion of a single-phase system into amulti-phase system; especially the separation of two immiscible blocksof a block co-polymer into two phases, with the possibility of a smallinterphase in which a small degree of mixing occurs. Some embodimentsmodify common commercially available hydrophobic thermoset orthermoplastic polymers, such as polyurethane or ABS to provide suitableproperties, such as strength, lubricity, electrical conductivity andwear-resistance. Other possible hydrophobic thermoset or thermoplasticpolymers are described below. Embodiments can include IPN and semi-IPNcompositions, as well as articles made from such compositions andmethods of using such articles. The IPN and semi-IPN compositions of tmay attain one or more of the following characteristics: High tensileand compressive strength; low coefficient of friction; high watercontent and swellability; high permeability; biocompatibility; andbiostability.

As disclosed herein, a method, system, or device for treating an OCD mayprovide a treatment solution that is optimized for the particular OCD ofa particular patient and may increase the likelihood that mobility willbe restored to the joint because an implant model is generated for eachOCD of each patient.

In addition, the teachings of the present disclosure may increase thelikelihood of restoration of the weight bearing properties of the jointbearing the OCD because of the use of the database of healthy boneanatomies to generate a 3D healthy bone model restores the normalcontours of the bone that may have been destroyed by the OCD.

Moreover, the teachings of the present disclosure may increase thelikelihood of cartilage and/or bone growth because of the distinctoptimized structures of the segments of the implant, the ability toinject biologic enhancements into the segments of the implant fortargeted tissue growth, and the channels of the implant that areconfigured to facilitate blood flow into one or more segments of theimplant.

Furthermore, the teachings of the present disclosure may increase thelikelihood of restoration of the native articular surface because of thedistinct segments of the implant that localize cartilage growth to onesegment of the implant and bone growth to a second segment of theimplant.

While various illustrative embodiments incorporating the principles ofthe present teachings have been disclosed, the present teachings are notlimited to the disclosed embodiments. Instead, this application isintended to cover any variations, uses, or adaptations of the presentteachings and use its general principles. Further, this application isintended to cover such departures from the present disclosure that arewithin known or customary practice in the art to which these teachingspertain.

In the above detailed description, reference is made to the accompanyingdrawings, which form a part hereof. In the drawings, similar symbolstypically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the presentdisclosure are not meant to be limiting. Other embodiments may be used,and other changes may be made, without departing from the spirit orscope of the subject matter presented herein. It will be readilyunderstood that various features of the present disclosure, as generallydescribed herein, and illustrated in the Figures, can be arranged,substituted, combined, separated, and designed in a wide variety ofdifferent configurations, all of which are explicitly contemplatedherein.

The present disclosure is not to be limited in terms of the particularembodiments described in this application, which are intended asillustrations of various features. Many modifications and variations canbe made without departing from its spirit and scope, as will be apparentto those skilled in the art. Functionally equivalent methods andapparatuses within the scope of the disclosure, in addition to thoseenumerated herein, will be apparent to those skilled in the art from theforegoing descriptions. It is to be understood that this disclosure isnot limited to particular methods, reagents, compounds, compositions orbiological systems, which can, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein are generally intended as “open” terms (for example, theterm “including” should be interpreted as “including but not limitedto,” the term “having” should be interpreted as “having at least,” theterm “includes” should be interpreted as “includes but is not limitedto,” et cetera). While various compositions, methods, and devices aredescribed in terms of “comprising” various components or steps(interpreted as meaning “including, but not limited to”), thecompositions, methods, and devices can also “consist essentially of” or“consist of” the various components and steps, and such terminologyshould be interpreted as defining essentially closed-member groups.

In addition, even if a specific number is explicitly recited, thoseskilled in the art will recognize that such recitation should beinterpreted to mean at least the recited number (for example, the barerecitation of “two recitations,” without other modifiers, means at leasttwo recitations, or two or more recitations). Furthermore, in thoseinstances where a convention analogous to “at least one of A, B, and C,et cetera” is used, in general such a construction is intended in thesense one having skill in the art would understand the convention (forexample, “a system having at least one of A, B, and C” would include butnot be limited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, et cetera). In those instances where a convention analogous to“at least one of A, B, or C, et cetera” is used, in general such aconstruction is intended in the sense one having skill in the art wouldunderstand the convention (for example, “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, et cetera). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, sample embodiments, or drawings, should be understood tocontemplate the possibilities of including one of the terms, either ofthe terms, or both terms. For example, the phrase “A or B” will beunderstood to include the possibilities of “A” or “B” or “A and B.”

In addition, where features of the disclosure are described in terms ofMarkush groups, those skilled in the art will recognize that thedisclosure is also thereby described in terms of any individual memberor subgroup of members of the Markush group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible subrangesand combinations of subranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal halves, thirds, quarters, fifths,tenths, et cetera. As a non-limiting example, each range discussedherein can be readily broken down into a lower third, middle third andupper third, et cetera. As will also be understood by one skilled in theart all language such as “up to,” “at least,” and the like include thenumber recited and refer to ranges that can be subsequently broken downinto subranges as discussed above. Finally, as will be understood by oneskilled in the art, a range includes each individual member. Thus, forexample, a group having 1-3 components refers to groups having 1, 2, or3 components. Similarly, a group having 1-5 components refers to groupshaving 1, 2, 3, 4, or 5 components, and so forth.

The term “about,” as used herein, refers to variations in a numericalquantity that can occur, for example, through measuring or handlingprocedures in the real world; through inadvertent error in theseprocedures; through differences in the manufacture, source, or purity ofcompositions or reagents; and the like. Typically, the term “about” asused herein means greater or lesser than the value or range of valuesstated by 1/10 of the stated values, e.g., ±10%. The term “about” alsorefers to variations that would be recognized by one skilled in the artas being equivalent so long as such variations do not encompass knownvalues practiced by the prior art. Each value or range of valuespreceded by the term “about” is also intended to encompass theembodiment of the stated absolute value or range of values. Whether ornot modified by the term “about,” quantitative values recited in thepresent disclosure include equivalents to the recited values, e.g.,variations in the numerical quantity of such values that can occur, butwould be recognized to be equivalents by a person skilled in the art.

Various of the above-disclosed and other features and functions, oralternatives thereof, may be combined into many other different systemsor applications. Various presently unforeseen or unanticipatedalternatives, modifications, variations or improvements therein may besubsequently made by those skilled in the art, each of which is alsointended to be encompassed by the disclosed embodiments.

1. A method of placing an implant to treat a defect associated with anarticular surface of a joint of a patient, the method comprising:receiving first data associated with the articular surface, the firstdata indicating a surface geometry of the articular surface; generating,using the first data, a bone model corresponding to bone tissueassociated with the articular surface; defining a geometry of thedefect; generating, using the bone model and the geometry of the defect,an implant model configured to treat the defect; receiving an implantcorresponding to the implant model; generating an implantation plan forthe implant, wherein the implantation plan comprises at least one of asize, a shape, a location, or an orientation of a cavity at thearticular surface that is configured to receive the implant; resectingthe articular surface to create the cavity; placing the implant into thecavity; receiving second data associated with the articular surface, thesecond data indicating a post-implantation surface geometry of thearticular surface; and determining, based on the post-implantationsurface geometry, whether a modification is needed to the implant forthe implant to be congruent with the articular surface.
 2. The method ofclaim 1, wherein receiving the first data comprises collecting, using aninstrumented probe configured to be identified by a tracking system tomap a surface, first surface point data associated with the articularsurface.
 3. The method of claim 1, wherein receiving the first datacomprises receiving a preoperative image of the articular surface. 4.The method of claim 1, wherein generating the implantation plancomprises: orienting the implant model with respect to the bone model;and determining the location and the orientation of the cavity accordingto an implant model orientation of the implant model with respect to thebone model.
 5. The method of claim 1, wherein the implant comprises atissue-interfacing surface configured to encourage bone growth into theimplant.
 6. The method of claim 1, wherein receiving the implantcomprises at least one of manufacturing the implant according to theimplant model or selecting the implant that best corresponds to theimplant model from a plurality of pre-existing implants.
 7. The methodof claim 1, wherein determining whether the modification is needed tothe implant comprises: receiving healthy bone anatomy data from adatabase; and comparing the post-implantation surface geometry to thehealthy bone anatomy data.
 8. The method of claim 1, further comprisingshaving or planing an implant articular surface of the implant,according to whether the modification is needed to the implant.
 9. Themethod of claim 8, wherein: the implant articular surface comprises asynthetic cartilage surface; and shaving or planing the implantarticular surface comprises shaving or planing the synthetic cartilagesurface until the synthetic cartilage surface smoothly interfaces withsurrounding bone tissue of the articular surface of the joint.
 10. Asystem for treating a defect associated with an articular surface of ajoint, the system comprising: a surgical system; a processor operablycoupled to the surgical system, the processor configured to: receive,from the surgical system, first data associated with the articularsurface, the first data indicating a surface geometry of the articularsurface; generate, using the first data, a bone model corresponding tobone tissue associated with the articular surface; receive a geometry ofthe defect; generate, using the bone model and the geometry of thedefect, an implant model defining an implant configured to treat thedefect; generate an implantation plan for the implant, wherein theimplantation plan comprises at least one of a size, a shape, a location,or an orientation of a cavity at the articular surface that isconfigured to receive the implant; receive second data associated withthe articular surface, the second data indicating a post-implantationsurface geometry of the articular surface; and determine, based on thepost-implantation surface geometry, whether a modification is needed tothe implant for the implant to be congruent with the articular surface.11. The system of claim 10, wherein: the surgical system comprises aninstrumented probe configured to be identified by a tracking systemcoupled to the processor to map a surface; and the first data comprisesfirst surface point data associated with the articular surface collectedvia the instrumented probe.
 12. The system of claim 10, wherein: thesurgical system comprises an imaging device; and the first datacomprises a preoperative image of the articular surface received fromthe imaging device.
 13. The system of claim 10, wherein the processor isconfigured to generate the implantation plan by: orienting the implantmodel with respect to the bone model; and determining the location andthe orientation of the cavity according to an implant model orientationof the implant model with respect to the bone model.
 14. The system ofclaim 10, wherein the processor is further configured to select theimplant that corresponds to the implant model from a plurality ofpre-existing implants.
 15. The system of claim 10, wherein: theprocessor is operably coupled to a database comprising healthy boneanatomy data; and the processor is configured to determine whether themodification is needed to the implant by: retrieving the healthy boneanatomy data from the database, and comparing the post-implantationsurface geometry to the healthy bone anatomy data.
 16. A surgical systemcomprising: a probe; a tracking system configured to intraoperativelytrack the probe; a processor; and a memory operably coupled to theprocessor, the memory storing instructions that, when executed by theprocessor, cause the processor to: receive, from the tracking system,first data associated with the articular surface obtained via the probe,the first data indicating a surface geometry of the articular surface;generate, using the first data, a bone model corresponding to bonetissue associated with the articular surface; receive, from the trackingsystem, a geometry of the defect obtained via the probe; generate, usingthe bone model and the geometry of the defect, an implant model definingan implant configured to treat the defect; generate an implantation planfor the implant, wherein the implantation plan comprises at least one ofa size, a shape, a location, or an orientation of a cavity at thearticular surface that is configured to receive the implant; receivesecond data associated with the articular surface, the second dataindicating a post-implantation surface geometry of the articularsurface; and determine, based on the post-implantation surface geometry,whether a modification is needed to the implant for the implant to becongruent with the articular surface.
 17. The surgical system of claim16, wherein the implantation plan is generated by: orienting the implantmodel with respect to the bone model; and determining the location andthe orientation of the cavity according to an implant model orientationof the implant model with respect to the bone model.
 18. The surgicalsystem of claim 16, wherein the memory stores further instructions that,when executed by the processor, cause the processor to select theimplant that corresponds to the implant model from a plurality ofpre-existing implants.
 19. The surgical system of claim 16, wherein: theprocessor is operably coupled to a database comprising healthy boneanatomy data; and the memory stores further instructions that, whenexecuted by the processor, cause the processor to determine whether themodification is needed to the implant by: retrieving the healthy boneanatomy data from the database, and comparing the post-implantationsurface geometry to the healthy bone anatomy data.
 20. The surgicalsystem of claim 16, wherein the tracking system comprises an opticaltracking system.